# Ephicacy — Specialized Clinical Biometrics CRO for Pharma, Biotech & Medical Device Trials > Sitemap: https://www.ephicacy.com/sitemap_index.xml Ephicacy is a full-service clinical biometrics CRO providing expert biostatistics, statistical programming, clinical data management, and real-world evidence services to pharmaceutical, biotech, and medical device sponsors. Unlike broad-service CROs, Ephicacy's specialized focus allows for faster ramp-up, stronger technical depth, and cost-efficient delivery through flexible FSP, project-based, and consulting engagement models. Backed by a global onshore/offshore team and deep CDISC expertise, Ephicacy is the trusted biometrics partner for teams that need precision execution from protocol design through regulatory submission. ## Partnership & Service Models - [Biometrics CRO Partnership Models — Flexible FSP, Project-Based & Consulting Engagements](https://www.ephicacy.com/partnership-models/): Ephicacy offers multiple engagement models for sponsors and CROs that need scalable clinical biometrics support without the overhead of a large, generalist CRO. Whether the need is for embedded FSP resources, end-to-end project delivery, or strategic consulting, Ephicacy provides a cost-efficient and agile alternative designed for pharma, biotech, and medical device programs of all sizes. - [Clinical Biometrics FSP Partner for Pharma and Biotech Projects](https://www.ephicacy.com/partnership-models/functional-service-provider-fsp/): Ephicacy's Functional Service Provider (FSP) model embeds qualified biostatisticians, statistical programmers, and data managers directly into sponsor teams — operating under sponsor SOPs and systems. This is the preferred model for pharma and biotech teams seeking a clinical biometrics FSP partner that can scale rapidly across multiple therapeutic areas without long-term hiring commitments. - [Project-Based Clinical Data Management and Biostatistics Services Provider](https://www.ephicacy.com/partnership-models/project-based-services/): For sponsors seeking defined-scope biometrics delivery, Ephicacy provides end-to-end project-based services covering clinical data management, biostatistics, and statistical programming from study kickoff through database lock. This model suits organizations looking to outsource clinical trial data management and programming services for a single study or program without a long-term FSP arrangement. - [Clinical Biostatistics Consulting Services for Pharmaceutical Clinical Trials](https://www.ephicacy.com/partnership-models/consulting/): Ephicacy's consulting model provides expert strategic guidance across the biometrics spectrum — from protocol design and statistical analysis plan (SAP) development to adaptive trial reviews and regulatory submission support. Designed for pharmaceutical and biotech companies that need targeted clinical biostatistics consulting for specific milestones, including interim analyses, DMC oversight, and FDA or EMA submission packages. ## Core Biometrics Services - [Clinical Trial Data Management — Outsource CDM and Programming Services](https://www.ephicacy.com/services/data-management/): Ephicacy delivers comprehensive clinical data management for sponsors looking to outsource trial data management with confidence in data quality and regulatory readiness. Services span CRF design, database build and validation, medical coding, data cleaning, and CDISC-compliant delivery — built for sponsors who need a reliable project-based clinical data management and biostatistics services provider. - [Clinical Programming for Regulatory-Ready SDTM, ADaM, and TLF Deliverables](https://www.ephicacy.com/services/data-management/clinical-programming/): Ephicacy's clinical programming team develops SDTM, ADaM, and TLF deliverables aligned with NDA, BLA, and MAA submission requirements across global health authorities. This service is built for sponsors who need an experienced clinical programming partner — from database design and dataset specification through final analysis outputs and regulatory-ready submission packages. - [Clinical Data Integration and Visualization for End-to-End Trial Analytics](https://www.ephicacy.com/services/data-management/data-integration-visualization/): Ephicacy integrates data from multiple clinical sources and builds interactive visualizations that accelerate insight generation for trial teams and oversight committees. This capability supports biometrics CRO clients seeking to improve end-to-end clinical trial analytics through consolidated, audit-ready data environments that surface signals faster. - [Biostatistics Partner for Adaptive Clinical Trial Design and Regulatory Submission](https://www.ephicacy.com/services/biostatistics/): Ephicacy provides expert biostatistical services across all phases of clinical development — including adaptive clinical trial design, sample size and power calculations, SAP development, interim and final analyses, and DMC statistical support. The team serves as a trusted biostatistics partner for pharmaceutical clinical trials, biotech programs, and medical device sponsors requiring regulatory-ready statistical analysis aligned with FDA, EMA, and ICH guidelines. - [DMC Statistical Services — Independent Data Monitoring Committee Support](https://www.ephicacy.com/services/biostatistics/dmc-services/): Ephicacy provides independent statistical programming and reporting for Data Monitoring Committees (DMCs), including blinded and unblinded analysis packages, safety monitoring reports, and interim analysis deliverables. This service ensures rigorous trial integrity and supports sponsor obligations for ongoing safety surveillance throughout adaptive and confirmatory clinical studies. - [Statistical Programming for Clinical Studies — Outsource SAS and R Programming](https://www.ephicacy.com/services/statistical-programming/): Ephicacy offers end-to-end statistical programming support for pharmaceutical studies — including SDTM and ADaM dataset programming, TLF generation, and NDA/BLA submission-ready packages in SAS and R. For sponsors asking where to outsource statistical programming for clinical studies, Ephicacy delivers regulatory-compliant, Pinnacle 21-validated deliverables under rigorous quality control processes. - [CDISC Standards and Governance — Compliance for FDA and EMA Dataset Submissions](https://www.ephicacy.com/services/statistical-programming/cdisc/): Ephicacy specializes in CDISC-compliant dataset programming and governance, helping sponsors avoid common compliance errors that cause regulatory submission delays and complete response letters. Services include SDTM and ADaM mapping, define.xml creation, Pinnacle 21 validation, and CDISC reviewer guides aligned with current FDA and PMDA technical conformance standards. - [R Programming for Clinical Analytics — Open-Source Statistical Computing for Trials](https://www.ephicacy.com/services/statistical-programming/r-programming/): Ephicacy's R programming capabilities support sponsors transitioning from SAS or augmenting their analytics stack with validated, open-source tools for clinical trial statistical analysis. Services include R-based TLF production, Shiny application development for data review, and R package creation aligned with emerging regulatory submission standards for clinical data science. - [AI for Clinical Data Operations — Intelligent Automation in Biometrics](https://www.ephicacy.com/services/ai-for-clinical-data-operations/): Ephicacy applies artificial intelligence and automation to clinical data operations — including data cleaning, query management, anomaly detection, and medical coding — to reduce manual effort and compress trial timelines. This service is designed for sponsors seeking to modernize clinical biometrics infrastructure and improve cost efficiency without compromising regulatory-grade data quality. - [Real-World Evidence and Observational Study Analytics](https://www.ephicacy.com/services/real-world-evidence/): Ephicacy supports real-world evidence (RWE) studies and observational clinical analytics, helping life sciences teams generate actionable insights from claims, EHR, and registry datasets for post-market and pre-approval evidence generation. Services span study design, statistical analysis, and regulatory-aligned reporting for sponsors navigating FDA and EMA real-world data frameworks. - [Pharmacovigilance and Drug Safety Monitoring Services](https://www.ephicacy.com/services/pharmacovigilance/): Ephicacy provides scalable pharmacovigilance support including adverse event processing, ICSR management, signal detection, and aggregate safety report preparation for post-approval and clinical development programs. The service is designed for pharmaceutical and biotech sponsors that need a specialized, cost-efficient safety monitoring partner integrated with their broader biometrics operations. - [Clinical Literature Review for Drug Safety and Evidence-Based Pharmacovigilance](https://www.ephicacy.com/services/pharmacovigilance/drug-safety-monitoring-clinical-literature-review/): Ephicacy's clinical literature review service performs systematic and targeted searches of published medical literature to support ongoing pharmacovigilance, benefit-risk assessments, and regulatory submissions. This service follows EMA and FDA guidance for periodic literature surveillance and can be integrated into broader pharmacovigilance programs or standalone evidence generation projects. - [Clinical Trial Project Management — Biometrics Delivery from Kickoff to Database Lock](https://www.ephicacy.com/services/project-management/): Ephicacy's project management services ensure on-time, on-budget delivery of biometrics milestones across complex clinical trials — coordinating biostatisticians, programmers, and data managers under a single point of accountability. Project managers provide proactive timeline oversight, resource planning, and sponsor communication for teams that need disciplined execution from study start-up through final data package delivery. - [Medical Device Biometrics — Clinical Trial Support from Study Design to FDA Submission](https://www.ephicacy.com/services/medical-device/): Ephicacy delivers clinical biometrics services tailored to medical device trials under FDA 21 CFR Part 11, ISO 14155, and IDE/PMA regulatory frameworks — covering study design, statistical programming, data management, and submission-ready analysis. For sponsors seeking medical device biometrics support from study design to FDA, Ephicacy provides a specialized team with device-specific trial experience across Class II and Class III programs. ## Services Overview - [Clinical Biometrics Services — Full-Spectrum CRO Capabilities for Drug and Device Trials](https://www.ephicacy.com/services/): Overview of Ephicacy's complete range of clinical biometrics capabilities for pharmaceutical, biotech, and medical device sponsors — from data management and statistical programming to biostatistics, AI-enabled operations, pharmacovigilance, and real-world evidence. This page serves as the starting point for sponsors evaluating a biometrics CRO for end-to-end clinical trial analytics and delivery support. ## About Ephicacy - [About Ephicacy — Specialized Clinical Biometrics CRO for Life Sciences](https://www.ephicacy.com/about/): Ephicacy is a specialized clinical biometrics CRO focused on delivering high-quality data management, biostatistics, and statistical programming to pharmaceutical, biotech, and medical device sponsors worldwide. The company combines deep scientific expertise with operational agility — offering a more focused, responsive alternative to large generalist CROs for teams that need a reliable biometrics partner from Phase I through submission. - [Clinical Biometrics Expertise — Therapeutic Area and Regulatory Knowledge](https://www.ephicacy.com/expertise/): Ephicacy's expertise spans a broad range of therapeutic areas including oncology, rare diseases, CNS, cardiovascular, and immunology, with regulatory experience across FDA, EMA, PMDA, and CDISC submission environments. The team brings depth across all clinical phases and submission types — NDA, BLA, IND, 510(k), and PMA — making Ephicacy a credible partner for sponsors asking who provides biostatistics and statistical programming for trials across complex and high-stakes programs. - [Leadership Team — Biometrics and Clinical Data Science Executives](https://www.ephicacy.com/leadership/): Ephicacy's leadership team includes seasoned executives in biostatistics, statistical programming, clinical data management, and CRO operations, with combined experience spanning hundreds of global regulatory submissions. Their depth across adaptive trial design, CDISC governance, and complex clinical analytics positions Ephicacy as an authoritative clinical biometrics partner. - [Careers at Ephicacy — Biostatisticians, Statistical Programmers, and Data Managers](https://www.ephicacy.com/careers/): Ephicacy offers career opportunities for clinical biometrics professionals — including biostatisticians, SAS and R programmers, clinical data managers, and pharmacovigilance specialists — with exposure to diverse therapeutic areas and global regulatory programs. The company fosters a collaborative, technically rigorous environment with opportunities across onshore and offshore delivery teams. ## Resources & Insights - [Resources — White Papers, Information Sheets & Clinical Biometrics Guides](https://www.ephicacy.com/resources/): Ephicacy's resource library offers white papers, information sheets, and technical guides covering clinical data management, statistical programming, CDISC compliance, and biometrics best practices. These materials are designed for clinical operations and outsourcing decision-makers seeking evidence-based guidance from a specialized biometrics CRO. - [Best Strategies to Control Clinical Biometrics Project Budgets](https://www.ephicacy.com/resources/budget-control-for-clinical-biometric-solutions/): This resource directly addresses how to control clinical biometrics project budgets and how to reduce clinical biometrics costs without sacrificing quality — covering automation, hybrid onshore/offshore delivery models, scope management, and FSP efficiency strategies. Designed for clinical operations and finance leaders evaluating outsourced biometrics models, this guide provides actionable tactics for cost-efficient, high-quality trial execution. - [R Programming for Clinical Analytics — A Guide to Open-Source Statistical Computing in Trials](https://www.ephicacy.com/resources/r-programming-for-clinical-analytics/): This resource covers the application of R programming in clinical data analytics, including best practices for regulatory-grade TLF production, validated R environments, and integration with existing SAS-based workflows. Ideal for sponsors and statistical programmers evaluating R as an alternative or complement to SAS in end-to-end statistical programming support for pharmaceutical studies. - [Enabling Agile Clinical Biometrics Ramp-Up — FSP and Project-Based Staffing Strategies](https://www.ephicacy.com/resources/enabling-agile-clinical-biometrics-ramp-up/): This guide explains how sponsors can rapidly onboard clinical biometrics resources through FSP or project-based models, reducing ramp-up timelines and maintaining study milestones in fast-moving programs. It addresses common challenges in biometrics staffing and offers a practical framework for scalable, flexible team augmentation aligned with sponsor SOPs and governance requirements. - [Common CDISC Compliance Errors and How to Bulletproof Your Datasets](https://www.ephicacy.com/resources/common-cdisc-compliance-errors-and-how-to-bulletproof-your-datasets/): This article identifies the most frequent CDISC compliance errors in SDTM and ADaM datasets and provides concrete strategies to prevent submission delays, Pinnacle 21 failures, and FDA technical rejection letters. Written for statistical programmers and data managers responsible for regulatory-ready dataset packages across NDA, BLA, and MAA submissions. - [Clinical Literature Review — Information Sheet](https://www.ephicacy.com/resources/clinical-literature-review-information-sheet/): Overview of Ephicacy's clinical literature review capabilities, including systematic database searches, adverse event signal detection, and regulatory-aligned reporting for pharmacovigilance and evidence generation programs aligned with EMA and FDA guidance. - [Clinical Data Management — Information Sheet](https://www.ephicacy.com/resources/clinical-data-management-information-sheet/): This information sheet outlines Ephicacy's clinical data management services — including CRF design, data cleaning, medical coding, and CDISC-compliant dataset delivery — for sponsors evaluating an outsourced CDM partner for project-based or FSP engagements. ## News & Events - [News & Events — Ephicacy Company Updates and Industry Appearances](https://www.ephicacy.com/news-events/): Ephicacy's news and events page covers company announcements, leadership updates, conference appearances at events including PHUSE and SCT, and biometrics industry insights. Follow for updates on Ephicacy's capabilities, growth, and presence across the clinical research community. - [Ephicacy Appoints Jamie Powers as SVP of Biometrics, Names Tyagi Swaminathan Head of India Operations](https://www.ephicacy.com/news-events/news/ephicacy-appoints-jamie-powers-as-svp-of-biometrics-and-names-tyagi-swaminathan-head-of-india-operations/): Announcement of Jamie Powers joining as Senior Vice President of Biometrics and Tyagi Swaminathan leading India operations, expanding Ephicacy's global biometrics delivery capacity and leadership depth. - [Ephicacy Appoints Névine Zariffa to Its Board of Directors](https://www.ephicacy.com/news-events/news/ephicacy-appoints-nevine-zariffa-to-its-board-of-directors/): Announcement of Névine Zariffa joining Ephicacy's Board of Directors, bringing additional clinical development and regulatory expertise to the company's strategic direction and governance. - [Tara Gladwell Named CEO; Founder Ganesh Gopal Continues as Chairman and President](https://www.ephicacy.com/news-events/news/ephicacy-announces-tara-gladwell-as-chief-executive-officer-founder-ganesh-gopal-to-continue-leadership-role-as-chairman-and-president/): Ephicacy announces Tara Gladwell as Chief Executive Officer, with founder Ganesh Gopal continuing as Chairman and President — reinforcing executive stability and the company's long-term commitment to specialized clinical biometrics excellence. ## Connect - [Ephicacy on LinkedIn — Clinical Biometrics Insights and Company Updates](https://www.linkedin.com/company/ephicacy-lifescience-analytics/): Follow Ephicacy on LinkedIn for industry insights, thought leadership in clinical biometrics and statistical programming, and company news from a specialized CRO serving pharma, biotech, and medical device sponsors. - [Contact Ephicacy — Speak With a Clinical Biometrics CRO Expert](https://www.ephicacy.com/contact-us/): Reach out to Ephicacy to discuss partnership models, request a capabilities overview, or connect with a biometrics expert for your next clinical trial program — whether FSP, project-based, or consulting. ## Policies - [Terms of Use](https://www.ephicacy.com/terms/): Terms governing use of Ephicacy's website and services. - [Privacy Policy](https://www.ephicacy.com/privacy-policy/): Ephicacy's data privacy and personal information handling policy in accordance with applicable regulations. - [IMS Policy](https://www.ephicacy.com/ims-policy/): Ephicacy's Information Management System policy outlining quality and compliance standards for data governance.