Clinical Trials, Research Operations, Pharma & Biotech & Life Sciences

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CRO
Clinical Trials & CRO - Research Operations

eKriya, holds a leadership role in this space as full fledged Functional Service Provider [covering end to end Clinical Research Operations, Clinical Trial I,II,III,IV phases, Bio-statistics, Regulatory & CRF protocols Submission services, Medical coding, Risk Plans, Clinical Pharmacovigilance, Patient & Site monitoring and remote / paper / electronic data capture and management [EDC, EDI, RDC], & Investigative services], primarily because of our strategic offshore BPO center [one of the largest CROs based in India], and proven models employed by our domain experts globally.

Some of the track record highlights of our global CRO services spanning geographically Continents:Americas, Eastern & Western Europe, Asia-Pacific, Australia | Countries: USA, Canada, France, Australia, Argentina, Czech Republic, China, India, Singapore, Indonesia, Malaysia, Philippines, Thailand & Vietnam, Ukraine, Russia, Romania, Bulgaria, Turkey, Pakistan, SriLanka, Bangladesh, include the following but not limited to,

  • 6 of the Top 10 Global Pharma MNCs |
  • 30+ years of combined professional domain expertise and experience |
  • 250+ successful execution of Clinical Data Mgmt. projects |
  • 200+ Electronic & Paper CRF | 27 multi-centric EDC studies |
  • Phase I = ~100+ | Phase II ~100+ |
  • Phase III = 260+ | Phase IV = 250+ |
  • 80+ clients world wide | 400+ network sites |
  • 34+ clinical trials with 4 INDs & 4 ANDAs |  
  • 16 vaccine clinical trials- studies on Hepatitis B, Measles, TT, DT, DTP, DTP-HB, DTP-HB-Hib, Hib, JE, H1N1 Swine Flu, Rabies, Varicella & Meningitis vaccines |
  • Medical Writeups117 CSRs | 82 protocols | ~5000 SAE narratives |
  • Regulatory Agencies: FDA, EMEA, DCGI, WHO, BFDA |  
  • ISO 9001:2008 certified processes |
  • Therapeutic Areas: Anti-Infective, COPD, Cardiovascular, Dermatology, Diabetes, Epidemiology, Endocrinology, Fermented diary products, Gastroenterology, Gynecology, Haematology, Immunology, Nephrology, Nutrition, Neurology, Oncology, Ophthalmology, Orthopedic,    Rheumatology, Respiratory, Psychiatry, Pulmonology.

Our knowledgeable & scholarly associates and medical field partners, in this space have demonstrated high standards rising the bar industry wide in overcoming above mentioned challenges and in offering reliable and highly rated outcomes with client desired results efficiently and effectively.

FSP
Clinical Trials CRO Functional Service Provider:
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As a full-fledged Functional Service Provider we give high priority in reducing our customer’s cost / pricing impact and meeting the expectations of various matrix, multi-vendor setups of customer stakeholders, offering best of both worlds, 1) select local stand-alone or 2) international studies and adherence to ANDA, WHO, IND, ICH-E6 & CSRs ICH-E3 etc.. regulatory protocols.

We have developed very flexible, scalable & interoperable service models and infrastructure for proven techno functional frameworks backed by relevant study specific domain expertise catering to small/ medium/ large group size customers and alliances over many years.

eKriya‘s prime offering broadly in this space is to Setup | Test | Use & Transform clinical research and trial processes spanning phase I thru phase IV with Robust, Reliable, Results driven Standardized Operating Procedures, both on-premise and remotely  for clients globally including services related to regulatory agencies and matrix partners.

  • Fully committed to be an end to end Functional Service Provider and offer Consultation level Design, Development, Implementation, Data Mgmt |
  • Preparation and presentation of Statistical Studies, Methods & Analysis, Regulatory Reports, Support for clinical trial Phases I thru IV |
  • Improve research and development efficiency while managing and reducing risk | 
  • Enhance operational efficiency and outcomes in clinical trial mgmt.|
  • > Platforms Offered: SAS, SPSS, Oracle Clinical 4.5.3 ®, SyMetric 9.1.12, Oracle® Argus Safety™ Suite, Oracle® AERS, ARISg | 
  • Implementation and Validation of Oracle® Argus Safety™ Suite, Oracle® AERS, ARISg, and other commercial off the shelf adverse event reporting systems |
  • >> Data collection: Modern [EDI, EDC] Electronic Data Interchange, Electronic Data Capture along with traditional paper, Scan/ Fax/ Hardcopy, Remote Data Capture – Oracle Clinical have become defacto methods of data management for all clinical trials phases
  • Increase clinical trial decision-support with clinical analytics. 
  • Improve adverse event and complaint management processes, while conducting globally consistent investigation, analysis, regulatory reporting and follow-up. 
  • Improve product quality and compliance. Increase marketing and sales effectiveness. 
  • >> E-Submission Gateway Set-up, Pilot Testing with Agencies including FDA and EMEA. 
  • >> Requirement specification and system selection.
  • >> Drug safety and regulatory reporting services:
  • Preparation & presentation of INDs, NDAs, BLAs, CTDs| 
  • Development Safety Update Reports (DSUR’s) |
  • Periodic Safety Update Reports (PSUR’s) | 
  • Suspected Unexpected Serious Adverse Reaction (SUSAR’s)|
  • Drug Master Files (DMF’s) | Trail Master Files (TMF’s)|
  • Investigator Brochures (IB’s) | Protocol Writing |
  • Inform Consent Forms(ICF’s) | Common Technical Documents (CTD/eCTD’s)|
  • Clinical Trail Application (CTA)| Market Authorization  Application(MAA)|
  • New Drug Application (NDA) | Annotated New Drug Application (ANDA) | Biological Application (BLAs)|
  • Supplementary New Drug Application(s-NDA), Investigational New Drug (IND),510k |
  • Protocols and amendments, PILs/ICFs IBs, CSRs (full, abbreviated, and synoptic reports)
  • Deliver more effective and personalized interactions with closed-loop marketing. 
  • Provide a 360-degree view of the customer and optimize interactions at every touch-point. 
  • >> Post go live support to address system administration, application administration and business support.
Regulatory
Clinical Trials & Regulatory Submission Services:
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eKriya aims at empowering the clients in meeting their project’s objectives in regulatory space while leveraging extensive experience in Regulatory Submissions including complex multinational submissions for Phase II-IIIb clinical trials. 

eKriya‘s well versed and highly qualified functional experts and associates provide bio-statistical support at regulatory meetings, symposiums worldwide.

We offer  full coverage of compliance verification of each submission from quality control review perspective  with reference to applicable guidelines. We are committed to ensuring the success of your trial. eKriya provides the following Regulatory Services – ,

  • Full coverage of Strategy | Submissions Planning |
  • Content Authoring | Component Coordination |
  • Assembly | Publishing | Internal Review |
  • Dispatch and Archiving | Registration Management |
  • Labeling Management | Health Authority Correspondence |
  • Commitment Tracking | and Regulatory Intelligence into consideration.

Some of the highlights in regulatory document and submission production include the below but not limited to: 

  • >> Preparation of Data Management Plan | Study Setup and Configuration | Case Report Form(CRF) Design and Database Programming | 
  • >> Edit Check Programming | Data Transfers from LAB /External Systems.
  • >> Full coverage of compliance verification of each submission from quality control review perspective  with reference to applicable guidelines and eKriya focuses on reducing the potential refusal-to-file issues. 
  • >> Remote Data Capture(RDC) Implementation | Discrepancy Mgmt. 
  • Adverse Events Integration| Data Base Administration (DBA)| Reporting Services.
  • >>  Abbreviated new drug applications (ANDA)|
  • Biologics license applications (BLA) | Drug master files (DMF) | 
  • Clinical trial uthorization/application/exemptions (CTA/CTX) | 
  • Clinical trial notifications (CTN) | Common technical document (CTD) | 
  • Fast track applications Investigational Drug Exemptions (IDE)|
  • Investigational new drug applications (IND) | New drug applications (NDA).
  • >>Facilitate IRB & ISC DossierApplication, Preparation, Submissions and Approvals |
  • Critical appraisal and gap analysis for submissions with fast turn around suggestions,recommended solutions for both paper and electronic submission services.
SOPs
Clinical Trials & General List of SOPs:
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  • Project Management SOP
  • Communication Reference Code SOP
  • Filing Procedure SOP
  • Review of informed consent process SOP
  • Investigator Meeting SOP
  • Clinical Trial Agreement and Financial Disclosure SOP
  • Project Progress SOP
  • Site Identification and Selection SOP
  • Essential Documents Collection and Approval SOP
  • Site Initiation Visit SOP
  • Interim Monitoring Visit SOP
  • Change of CRA SOP
  • Site Close out SOP
  • Serious Adverse Event Reporting SOP
  • Detection and Management of Suspected Fraud SOP
  • Investigational Product Accountability SOP
  • Investigational Product Retrieval and Destruction SOP
  • Investigational Product Recall SOP
  • Regulatory Communication SOP
  • IEC/IRB Communications SOP
  • Vendor Selection SOP
  • Translated Document Review and Verification SOP
  • Case Report Form Retrieval and Transmission SOP
QA & Audits
Clinical Trials & Quality Assurance & Audits:
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eKriya is able to enrich the excellence of our clients in all of the facets of clinical research operations and trials primarily because of its global strategic alliances. Our partners and associates provide ISO 9000:2001 certified processes and quality services along with deep domain expertise and experience dealing with localized regulatory organizations. 

Quality control is one of the main pillar for success of CROs. We have an uncompromising attitude when it comes to quality assurance and regulatory protocols compliance and our teams engage in 24×7 ongoing quality and compliance assessments of all of the Clinical Trials based services that we undertake.

Internal Process Audits strengthening our top notch compliance practices with robust reliable and results yielding standard operating procedures backed by qualified vendors. Please refer to our Philosophy and Capabilities to learn more about our organization level domain specific expertise. We have extensive auditing mechanism and processes in place which are integral part of our CRO domain specific services.

  • >> Project audits |
  • >> Investigator files/Site Audits
  • >> Clinical Trial Master file audits |
  • >> Database audits
  • >> Statistical report audits |
  • >> Clinical study report audits
  • >> Regulatory submission audits |
  • >> Process Audits | Vendor Audits. 
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Patient & Medical Mgmt.
Clinical Trials - Patients Management & Medical Affairs:
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eKriya‘s Patient Recruitment Services Group serves as an integral  and strategic part of our entire gamut of CRO operations and Clinical Trials Projects and takes care of end to end appropriate vendor management and for end to end qualified & applicable patient management recruitment, retention activities with reference to project needs.

Our domain experts and alliances provide best practices in this patient recruitment and retention space and offer strategies in achieving key milestones in line with program’s road-map and objectives while serving as interface to a number of media outlets and our approved and validated vendors.

Subject safety and well-being is the primary focus of a clinical study. Our experienced group of physicians will serve as a link between our sponsors and the investigative sites.

We offer safety monitoring and medical management support to your clinical studies. Our team of physicians will leverage their clinical experience and practical knowledge in conduct of a clinical study.

Sponsors & Investigators
Clinical Trials & Sponsors, Investigators:

eKriya partnered with investigators in this space to work on studies for the world’s leading pharmaceutical, biotechnology and medical device companies and since there is widening gap between supply and demand for qualified and certified and experienced medical professionals to participate in clinical research.

To narrow this gap eKriya, while leveraging strategic alliances, offers a convenient platform to this sector allowing associates to be integral and contributing part of our expanding network. Our medical monitors shall provide: 

  • Protocol and study specific training to the investigator |
  • Response to subject evaluation criteria questions | 
  • Safety monitoring – AE and SAE management | 
  • Support in regulatory agency representation. 

eKriya strives to provide top notch clinical research operations and is committed to be the top level full service provider of choice to customers for clinical trials clinical trials, at global scale.

Post Marketing Studies
Clinical Trials - Post Marketing Studies:

Post Marketing Studies: Data entry into validated electronic database including historic safety data. Our experienced techno functional domain experts, statisticians, programmers, program / project managers ensure cadence and periodic interactions with client representatives for clinical trials study advisory and data safety and monitoring committee meetings.

  • Quality control, Medical review | narrative writing |
  • MedDRA coding| Reporting: Electronic (E2B) |
  • Hard copy (CIOMS, MedWatch 3500A drug, etc.)|
  •  Complete PSUR/PADER generation | Literature searches|
  • Signal Detection- Benefit Risk Evaluation & Risk Management

eKriya ensures the end to end support to client teams in making optimal decisions around analysis methodology interpretation and reporting, sample sizes, cohorts, dependent and independent characteristics of cohorts, control groups, number of studies with high degree of accuracy and precision.

Site Monitoring
Clinical Trials & Site Monitoring:
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eKriya aims at exceeding the expectations of our clients in all the facets of clinical research operations and trials while leveraging extensive experience of our highly qualified ACRP certified CRAs | PMs, associates and expert professionals. 

eKriya offers high quality, data safety oriented site monitoring services. Broadly, some of our site monitoring services are – 

  • IRB/IEC application preparation, submission and approvals|
  • Clinical site management| Site initiation visits | Training of site personnel| 
  • Interim monitoring/co-monitoring visits |
  • Site close out visits | CRF retrieval | Query management|
  • Site specific regulatory binder creation and maintenance |Study materials supply management | Vendor supply management.
Statistcs & Randomization Studies
Statistics & Randomization Studies

Statistical Analysis & Randomization Studies– Our statisticians consult and generate various randomization schemes to meet your study requirements using an array of wide variety of methods in accordance with the industry best practices, aiming at probability of success of clinical trials.

  • >> Highly controlled and secured environment catering to the blinded envelope system, an interactive phone/web randomization system, or a simple open randomized schedule.
  • >> Provision of Statistical Programming, Sampling Study Methodology, Cohorts and Control groups data sets construction, match and listings, with source verification, relevant selection of variables and parameters
  • >> Data Integration – Access to a global pool of bio-statisticians and resources enhances our ability to integrate data from disparate and multiple sources. 
  • >>> Preparation of Statistical Analysis Plan |
  • Studies Design | Randomizations|
  • Protocol Preparation | Tests| ANOVA – Analysis of Variance |
  • Survival Analysis| Kaplan–Meier Survival Curve|
  • Pearson and Spearman Correlation |
  • Logistic Regression | Non Parametric Analysis | 
  • >> Complete end to end coverage for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for NDA and sNDA Submissions and preparation for submissions. 
  • >> End to end documentation and support for data safety monitoring boards.
  • >> Analysis artifacts for Planning thru final reports development stages with applicable interpretations and derivations in line with Business Requirements and subsequent conversions to tech specifications along with adhoc and interim analysis report requests.
  • >> SAS, SPSS and Oracle are most widely used and leading software technologies for analytics in this domain over past two decades. 

Our resident experts and associates mostly possess Masters, Post-Graduation, PHD, Doctorate & Post-Doctoral faculties & fellows of renowned academic institutions in the field and always carry on current initiatives based knowledge in legacy & emerging bio tech, CROs, Pharma, Life Sciences, Drug development & FDA medical regulations and controlling protocols while focused on expediting the drug submissions, evaluations and approvals meeting various regulatory agency specifications. 

  • >> For campaigns, promotions, regulatory, SOWs, pilot projects based clinical trials needs and study purposes, eKriya offers proven expertise and 3+ decades of domain experience from our skilled techno functional associates and experienced statisticians.
  • >> Expert consultation for statistical issues relating to drug discovery, formulation, laboratory development, clinical development, evaluation/approval, manufacturing, and marketing research.
  • >> Assistance in presenting statistical methods, studies, results and analysis reports to the regulatory agencies and authorities.
  • >> Design, Development & Verification of analysis reports per CRF protocols to ensure delivery of end to end clinical trial data management system backed by optimized statistical methods based error free and accurate resultsImplement lean manufacturing initiatives with flexible and agile manufacturing applications. 
Clinical Trials & Data Mgmt. Studies
Clinical Trials & Data Management.
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eKriya solves customers major challenges in Data Modeling, Profiling, Quality, Consistency & Reliability aspects by empowering clients with Accurate, timely Accessible, Insightful & Actionable Intelligence based Analytics while ensuring low costs coupled with expected medium to high ROI with relevant successful regulatory compliance during and post-launch/post marketed studies of clinical trial processes. Some of the below reflect our full range of data management services for clinical studies from phase I-IV of all sizes, as well as stand-alone projects compliant with 21 CFR Part 11 Requirements..

  • >> Assessment, Project Specific Clinical Data Management Plan
  • >> Data collection: Modern [EDI, EDC] Electronic Data Interchange, Electronic Data Capture along with traditional paper, Scan/ Fax/ Hardcopy, Remote Data Capture – [using tools SAS, SPSS, Oracle Clinical] have become defacto methods of data management for all clinical trials phases.
  • >> EDC- Extraction, Transformation, Loading. >>> Preparation of Data Management Plan | Study Setup and Configuration | Case Report Form(CRF) Design and Database Programming | Edit Check Programming | Data Transfers from LAB /External Systems | Remote Data Capture(RDC) Implementation | Discrepancy Management.
  • >> Paper / Manual data capture: Scanning the source documents and tagging the source data with electronic format | 21 CFR 11 Requirements Analysis | Preparation of Data Management Plan| Creation of Data Entry Screens | Creation of Edit Checks and Data Quality Checks | Tagging the data elements into CDISC compliant ODM data | Database Design | Thesaurus Integration | Double Data Entry | Verification and Validation Activities | Data Clarification and Query Resolution | Quality Control| Database Locking and Preparation for Submission | Project Management | DBA Services. 
  • >> Data Mapping | Source verification |  Data Modeling | Data Profiling | Data Validation
  • >> Customized Database Design & Development. Data Base Administration(DBA) Services | Reporting Services.
  • >> Edits, Validation and Design check programming | >> Duplicate, Double Data Entry Comparison and Adjudication
  • >> Data Stewardship & Standardization, ETL, Query Management. Feasibility study for data standardization | Business case preparation for implementing CDISCstandards | Translation of protocol into ODM, SDTM ready data elements | Custom solutions for conversion to CDISC standards | CDISC conformance audit on existing systems / tools/ standards | CDISC compliant tool selection | Interoperability analysis using ODM and LAB standards | Conversion of existing CDMS, CTMS systems to be CDISC compliant | Preparation of SDTM compliant data sets | Preparation of CRT data sets | Preparation of definition pdfs, xml type documents for submissions| Enhancements to existing Clinical Data Management System.
  • >> Dictionary Services (MedDra,WHODD or your own dictionary): >> Standards: Submissions Data Tabulation Model (SDTM) | Analysis Data Model (ADAM) | Operational Data Model (ODM) | Laboratory Data Model (LAB) | The Standard for Exchange of Non Clinical Data (SEND) | Clinical Data Acquisition Standards Harmonization (CDASH) | The Bio-medical Research Integrated Domain Group (BRIDG) |
  • >> Quality Control and Data Quality Audits
  • >> Data Listings, Database Lock and Export to SAS and other tools.
  • >> Statistical Data Samplings, Cohorts, Studies, Analytics, Insights, Listings, Tables, Graphs, Plots, Drafts.
  • >> Delivery of Clean Data Files
  • >> Project Data Archival and Documentation Storage: Design/ Implementation of Enterprise Document Management Solutions | Integration of different Document Management Solutions for CDMS | Integration of LAB and ECG data from multiple sites | CRF Data Conversion to documents | Configuration/ Administration | Lifecycle Management | Document Workflow Management Services | Docket Preparation (local and global).
  • >> Clinical Trials Documentation Services: Documentation Clinical Data Mgmt. Reports , Clinical Trial Summary (CSR) Reports, Analysis manuscripts. Typical use of technologies and related services include Documentum, Open Text and Adobe Solutions | Integration of existing Clinical Data Management Systems to Enterprise Document Management Systems.
Clinical Pharmacovigilance & Bio Statistics
Clinical Pharmacovigilance & Bio-Statistics:

Clinical Research with Bio-statistics reflect end to end spectrum of a drug compound from efficiency, efficacy, safety perspectives. eKriya‘s seasoned bio-statisticians offer deep domain expertise in complex areas of a study’s design, sample size, cohort’s characteristics, analysis methodology, required applicable statistical algorithmic data visualizations and interpretations while adhering with regulatory compliance guidelines, requirements & measures globally. Our consultants, associates come with in depth clinical, drug development and therapeutic domain specific techno functional processes based matured expertise enabling us to offer flexible and customization tailor made to unique requirements of customers targeting client’s business optimization.

Globally, while being abreast of latest technology and best practices in clinical applications and infrastructure leveraging our strategic alliances and thru our reliable medical, life sciences fields associated academics, Research & Development partnerships our services currently spanned across Americas, Western and Eastern Europe and Asia Pacific regions. As part of our sustainability, value chain & product life cycle management and solution consulting practice, our experts adapt lean / six sigma, TQM, JIT quality circles approaches and methodologies.

  • >> End to end clinical data management activities, Clinical Trials Safety Data Management, Clinical Study Reports and Annual Reports.
  • >> Review & Validation of Electronic Data Interchange EDI & Electronic Data Capture EDC, Historic Safety database management,  Quality Control.
  • >> Reporting: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.), Complete PSUR/PADER generation.
  • >> Medical review, Literature searches, Narration, MedDRA coding.
Safety & Risk Management
Safety & Risk Management

Safety & Risk Mgmt.: Managing Risk is paramount and integral part of all the facets of pharmacovigilance at eKriya and for all its global strategic alliances and partnering associates during clinical trials and post-launch/post market studies. 

  • >>Adverse Event Reporting Systems Integration| 
  • Configuration and Integration, Implementation and Validation of Oracle® Argus Safety™ Suite, Oracle® AERS, ARISg Systems  and other commercial off the shelf adverse event reporting systems
  • Adverse Signal Detection- Benefit Risk Evaluation |
  • Serious Adverse Event Reconciliation & Risk Mgmt.|
  • Patient Safety and Surveillance |
  • Coding – MedDRA, SNOMed | CIOMS Integration |
  • Drug safety and regulatory reporting business processes | Product Safety Update Reporting | WHO / COSTART integration | E-Submission Gateway Set-up, Pilot Testing with Agencies including FDA and EMEA | Requirement specification and system selection. 
  • CIOMS and Regulatory Reporting | Safety and Surveillance – Maintenance |
  • Custom Built applications | COTS Tool Selection and Implementation |
  • Enterprise Content Management / Data Mining Configuration and Implementation.
  • >> Triage 24 x 7 Calls & Receipts | 
  • Processing of SAEs & electronic reporting|
  • Causal factors assessment.

Use of right skills and leading technologies for data mgmt and analytics keeps us focused on planning to delivery time horizon and achieving the ultimate benefit of zero error execution. Our diversified, qualified & experienced communications specialists, medical, life sciences, drug, pharma & technology writers for medical science write-ups are backed by proficient quality assurance teams, highly experienced and visionary medical field academicians, practitioners.

Offerings
Summary of Offerings:
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> Reduce [TCO] Total Cost of Ownership of legacy business systems, processes and IT services and migration to newer low cost systems.

> Speedup Go-To Market Time and response to market demand and supply requirements.

>> Continuous Momentum Drive of multi-faceted digital transformation. Increase in Churn, Inventory Turns, demand supply balance, logistics, on-Time delivery.

>> Innovative Digitized Transformation for faster new services introduction e.g. new wellness programs, medical devices, clinical products [NPI]. >> Adaptation of smarter technologies around our processes and performance linked pricing.

>> Improve Return on Investment [ROI], Profitability with better margins for disease management, wellness programs etc..

>> Control Costs and Optimize procurement of medical devices lead times leading to faster growth. Collaborative Optimization. Beyond Enterprise Collaboration [SMAC] with suppliers, customers, employees, competitors.

>> Value Added Pursuit for Excellence tapping competitive market intelligence using informed decisions offering meaningful insights for utilization, clinical, financial benchmarks.

>> Infuse Agility. Enhance Ingenuity. Increase Efficiency in disease or wellness management programs, life sciences R&D.

>> Ensure Provider Compliance. Harness Synergies & Expectations e.g. investigative, corrective actions, audits against fraudulent claims analytic processes.

>> Achieve greater accuracy in health care information exchange based pricing models for patients, members, subscribers leveraging profiling and directories and data sharing, application services to implement & test claims based management solutions

>> Optimize, inter-operable data sharing services to patient, provider and business layer delivery mechanisms from industry partners.

>> Improve R&D effectiveness and reduce time-to-market for medical devices, pharmacy products, over the counter drugs and health care services.

>> Make informed decisions based on clinical outcomes, measures, quality and utilization for Disease Management, Care Management & Wellness Management programs and for Episode Treatment Groupings [ETG], Episode Risk Groupings [ERG], Risk Stratifications.

>> Data integration between payers, providers, HIEs, ACOs,  Aggregation of claims, encounter, ETG, ERG, membership and demographics.

>> Facilitate Sustainable, Measurable, Adaptable, Reliable and Transformational business and IT services & solutions addressing sector challenges.

eKriya offers extensively talented health care staff at all levels. Our teams provide reliable business programs and projects management as well as complex technical solutions leveraging deep dive analytics at various stages. eKriya’s associates offer a wide of range of skills, years of experience in various verticals of this sector.

Patient Subscriber Member Services
Subscriber | Member | Patient Services:
  • Member/ Subscriber/ Patient enrollment, engagement, care and retention into wellness, care, rehabilitation programs. Improve quality, healthcare utilization rates and disease management and wellness management associated KPIs.
  • Single version of truthful view of  health and wellness activity data. Member centric information management.
  • Reduction in outpatient physician office visits, health care costs. Enhance Standard Operating Procedures, Policy generation.
  • Increase patient engagement and convenience while enabling more efficient tools for clinicians by using mobile technologies to provide remote monitoring choices. Conform to the tough and ever changing regulatory and reporting norms.
  • Enhanced subscriber / member / patient wellness and care and safety through near real-time, remote monitoring of vital signs and Internet of Things based automated alerts. Continuous momentum of multi-faceted digital transformation of health care business processes.
  • Improve customer/patient acquisition and retention rates, life time value (for drug and medical device uptake and clinical trials).
  • Decrease the overall cost of healthcare by reducing fraudulent medical tests, procedures. Improving Operational efficiency and quality of care and customer loyal subscriptions.
  • Optimized, results boosting pricing models for drug formulary and medical devices. Strategically managed business objectives/outcomes oriented collaboration with wellness and care teams supported by actionable intelligence.
Medical Billing Coding Claims Administration
Medical Billing, Coding & Claims Data Administration

>> Medical Billing: Scanning & Indexing, Eligibility, Demographics Entry, Charge, Entry Claims Submission, EFT/ERA Processing, Payment Posting, Adjustments, Denials Capture

>> Medical Coding: ICD9 & ICD10, HCPCS, Coding Audits, Coding Denials, HCC/Chart Review.

>> Claims data administration: Claims data capturing, verification and digitization, Claims pre adjudication and adjudication, Claims processing and editing, Claims repricing and auditing.

>> Accounts Receivables: Status, Denial Management, Appeals & Resolution, Eligibility, Old A/R, Pre-Cert, Patient, Insurance, Credit Balance & Refunds.

End to End Health Care Management Analytics
End to end Health Care Mgmt. Analytics:

>> End-to-end Health Care data management: EDW, EBI, ETL, Data scrubbing, indexing storage and retrieval,  Business Processes, Data Analytics and Decision Support: Data analytics for identifying opportunities and threats, Providers Fraud analytics, Custom dashboards with balanced scorecards reflecting actionable intelligence and alerts. eKriya’s experts enrich clients analytical excellence in leveraging years of deep domain expertise, extended onsite/offsite hassle-free business process applications’ shared and outsourced service mechanisms, medical and pharma claims management targeted at higher operational efficacy and efficiency.

>> Integrate and optimize disparate data sources internal/external to the organization via federated, hybrid business architecture models. Integrating eligibility, membership, medical claims, pharmacy claims, GxP validated disparate data sources and generating sophisticated, composite performance measures via statistical sampling cohorts, models, analysis and algorithms.

>> Enterprise wide data warehousing and Clinical Insights via Enterprise business intelligence solutions using SAP HANA + HCP, SAS Enterprise Business Intelligence & Data Integration, OBIEE, SAP BoBJ, SPSS, WinNonlin, IBM Congnos, MicroStrategy, Tableu, Qlikview, Spotfire etc…

>> Performance and financial analytics, dashboards & reporting, end-to-end testing, statistical analytics using SAS, SAP, Oracle main stream technologies.

Integrated Health Care and Life Sciences Analytics

Integrated Health Care & Life Sciences Analytics

Health care is changing constantly. Reforms are adding the complexity to payers, providers and members. All patient centric, payer centric and provider centric models are undergoing massive sea change because of the advent of new regulations, reforms, mobile technology and “health care any where” concepts impacting the industry economies. These are commanding a change in the healthcare processes and making the operations cumbersome. Hence, dependency on Information technology increased by multi fold. Technology is calling for digital transformation. Cutting costs of Health care & Drug development, Clinical Trials is not an easy achievement. Today global healthcare organizations are grappled with increasing regulatory and legal hurdles.

Regulations like PPACA, Sustainable growth rate, reduction in Medicare and Medicaid funding to the tune of $450 billion over the next 7 years are not offering easy transformation and profits for providers. Provider groups are moving non-core activities to specialized organizations. Some of the very significant sector influencing opportunities here can be controlling the cash flow management and improving up on operational efficiency via programs and projects that align various matrices of this sector while influencing and addressing regulatory challenges, operational cost containment, increasing productivity and efficiency, scalability etc. core competencies.

eKriya’s consultants offer expertise in Revenue Cycle Management services and help our clients decrease A/R days and claims denials, accelerate cash flow and savings, eliminate regulatory compliance headaches, integrate your back office functions efficiently, ultimately leading to better customer services and creating a competitive advantage in the sector. Our healthcare team of consultants applies the best healthcare practices around the globe and employs finest resources including, technology, people and processes to help client achieve maximum result for the clients.

eKriya believes that latest digital technology intervention is the key and has very critical role in overall streamlining of operations. Our teams offer techno functional solutions that utilize emerging technologies and transforming business processes to deliver optimal results and are experienced in managing robust data interfaces with hundreds of payers for claims information, frequent contact and collaboration with US payers reduce the complexity of claims resulting in excellent A/R resolution rates.

eKriya’s clients leverage the strategic advantage of our BPO model through every step of the business process and technology transformation including training, installation, deployment, continued support, and 24/7 customer care.

Compliance & Regulations: Current era regulations demand continuous compliance which mandates the customization of business processes. EHR and EMR usage offers more state and federal benefits to providers. But, providers are not fully equipped with necessary technologies to tackle HIE, HL7, HIPAA, PPACA, EHR, EMR.

Compliance with requirements like CGMP, CFR Part 11, ICD9 to ICD10, Meaningful Use stage 1,2 and 3 constantly keeping payers and providers on toes. More and more challenges are piling up. American Patient Protection and Affordable Care Act (PPACA), HIEs, HIX make providers rethink about their patients engagement and retention strategies. Hence the need for providers to be more proactive and competitive in care management space. Insurance Payers need prevention strategies for fraudulent claims submission and non compliance from billing providers. Life Sciences and Pharma sectors are facing patent wars, high priced drug failures or withdrawals along with rising R&D, clinical trails costs.

eKriya’s experienced consultants dig out deep rooted meaningful insights and never loose focus on this paradigm shift. eKriya’s experts empower clients to offer qualitative accessibility of care and digital wellness to their members with high ROI yielding next generation solutions at every milestone of their program road maps aimed at winning their end subscribers, members. Our consultants having worked with several leading insurance companies, payers, providers, CROs and third party administrators enable our clients to create tailored solutions that reduce administration overheads, improve member and customer satisfaction, and provide flexibility to change with regulatory and market developments.

Our business processes, analytics, technology tools and services employed by our experts adapt six-sigma based methodologies combined with a global delivery model, help clients deliver outstanding results to their customers and members and exceed benchmarks in the industry while realizing significant cost savings.

As part of our corporate commitments SMART analytics with meaningful insights offering actionable intelligence becomes a mandatory standard offering to our customers in this vertical. We have made sure our alliances have passed the stringent quality standards and measures and follow ISO 9001-2000 certified processes, keeping the best interest of our clients.

Healthcare Informatics broadly adheres to the below framework.

  • Data Acquisition—Collection and storage of data from various sources such as instruments, manual data entry, and  system generated data, focusing on the right acquisition method for each source
  • Data Management—Data updates and data consistency, data security, change control and audit, data governance, data integrity, data quality, Mapping & Integration—Migration of data, data integration & harmonization of information from multiple data sources
  • Analysis—statistical analysis, data mining, etc..
  • Reporting—decision support, business intelligence, dashboards & balanced score cards

Some of the key focus areas in this space are mentioned below.

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Commitments

Infuse Agility. Enhance Ingenuity. 
Increase Efficiency. Innovate Digital Transformation. 
Collaborative Optimization. Continuous Momentum Drive. 
Reduce [TCO] Total Cost of Ownership. 
Speedup Go-To Market Time. 
Improve Return on Investment [ROI]. 
Harness Synergies & Expectations.
Pursuit for Value Added, Excellence. 
Facilitate Sustainable, Measurable, Adaptable, 
Reliable & Transformational Services & Solutions.

Strategic Capabilities for Global Markets

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In 21st Century, markets of all verticals globally, are transforming and adapting to daily complex changing needs. Advent of Internet of Things has opened up new online market avenues. Gap between demand from end consumers and supply from enterprises with products and services is experiencing widening imbalance, across world markets. When underlying business processes of an enterprise are reverse engineered / restructured and related SLAs are tightened to meet the emerging demands and new opportunities, balanced levels between supply and demand can be reestablished.
eKriya‘s teams of domain experts, program managers, solution architects, developers, top notch technical consultants use best practices, with deep industry and sector’s line of business specific expertise, empowering the clients move towards Digital Transformation, across the industry verticals, globally.
eKriya‘s systems integration design development services help clients enhance value of processes and drive the transformation to next levels.
eKriya‘s talented professionals help clients design, develop and integrate the systems and applications that best run their business. As an end-to-end IT services provider, our consultants offer deep domain specific expertise in all facets of clients’ business and technology environments, enabling us consult, implement and manage solutions.
eKriya‘s techno-functional services are complemented by best-fit global delivery models per client needs to provide the required combination of value and expertise. 

Through our associates’ decades of experience in bringing together and optimizing systems and applications, eKriya provides specialized solutions expertise in the following practice areas and services such as,

  • Enterprise Performance Management servicesEnterprise Business Data Analysis services, Enterprise SMO/PMO Mgmt. Consulting services, Business Intelligence services – helping organizations harness the power of big data and customer analytics to drive business value.
  • End to End Data Management services – ensuring data availability, the efficient response to end user requests, and the adaptation to a constantly growing infrastructure,
  • Clinical Research Operations– full-fledged Functional Services ProviderClinical Trials data management systems for healthcare, life sciences, Pharma, Biotech sectors,
  • Enterprise Application Integration services – providing effective integration of applications to support business processes and achieve business results,
  • Enterprise Architecture services – orchestrating and aligning people, processes and technology infrastructures to improve the performance of an enterprise’s architecture functions,
  • Enterprise Content Management services– making pertinent data more accessible across the enterprise to improve performance and productivity and to reduce cost and risk,
  • Enterprise Resource Planning services– helping clients get the most from their ERP investments such as Oracle and SAP,
  • Geo-spatial services, Information Security services – implementing proactive, business-aligned enterprise security strategies that improve risk management, productivity, data integrity and compliance,
  • SMART IOE, IOT, Data Science, ML, M2M, M2p, P2P, BIG Data, Social Mobile Analytical Cloud Computing – increasing productivity, improving service access and building customer loyalty through enterprise mobility solutions.

Please visit the link eKriya’s capabilities:

Capabilities: eKriya‘s Sources supports customers’ business and IT units with a mix of staffing and human resources functions as collateral services. eKriya‘s enterprise level capabilities broadly encompass the following business and IT services & practice areas.

  • Strategic Business & Technology Management Consulting, Business Case studies, Assessment Services |
  • Programs, Portfolios, Projects [PMO] Management Services |
  • Business Analysis, Processes Reverse Engg., Requirements, Communication & Change Management Services |
  • 3rd party Vendors, Products, Staffing & Resources Management Services |
  • Enterprise Information Systems Analysis, Architecture, Design & Engineering Services |
  • Applications Design, Development, Deployment & Maintenance [Desktop /  Web / Mobile] Services |
  • SMART IOE, IOT, BIG Data Science, ML, M2M, M2p, P2P, BIG Data, Social Mobile Analytical Cloud Computing, Relational database, OLAP, OLTP , Data warehouse, marts, cubes – Design, Dev., Administration & Maintenance
  • Functional & Technical Quality Analysis & Testing Services|
  • Database Development, Administration & Maintenance Services |
  • Business Intelligence & data warehouse Management Services |
  • Exec. Reporting, Balanced Scorecards, Dashboards, Statistical Analysis Services |
  • Managed IT Applications [On-premise / Remote / Cloud] Services |
  • Legacy Migration, Modernization & Sustainability Services.
Contact Us!!

Please feel free to email us. Support: shores@ekriya.us | Sales: sales@ekriya.us

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