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Accelerated R&D: Clinical Data Services

Standardizing clinical data to enable improved analytics, more efficient processes and streamlined regulatory submissions.


Accenture’s clinical data services enable life sciences organizations to transform their clinical data operations for greater business efficiency and streamlined regulatory submissions. We draw on our experience across the clinical data lifecycle and a body of work for clients in over 26 therapeutic areas. Our FDA legacy data conversion experience includes a contract to convert over 300 studies to SDTM and ADaM standards.

Through our worldwide network of global delivery centers, Accenture offers clients access to experienced clinical data teams within multiple geographic locations. More than 500 full-time clinical data professionals across North America, Europe and the Asia/Pacific Rim deliver the multi-platform experience and knowledge to manage and process clients’ clinical data requirements with precision, creating true assets in the downstream submission process.

Contact one of our R&D professionals for more information about our services:

US: North East
Jeff Emme
Tel: +1 610 407 5125

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US: South East & Mid Atlantic, West & Central
Kim Assal
Tel: +1 913 319 1259

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Outside of the US
Andy Gerrard
Tel: +44 (0) 203 626 1979

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Why Accenture

  • Cut costs: Our data conversion services minimize rework, reduce manual maintenance tasks, and improve communications. This helps reduce data conversion costs by 30–35 percent and shorten conversion times by 30–35 percent.

  • Decrease cycle times: We help companies implement CDISC standards to decrease cycle times—by as much as eight months in some cases.

  • Reduce rework: Our proprietary tools can be used to monitor and facilitate resolution of issues associated with submission component readiness.

  • Improve analytics:

  • Through standardized clinical data, we improve analysis capacity for faster and more flexible evaluations of compounds in development.

  • Facilitate better analytics to improve program design and assist in patient safety.

  • Enhance submission-readiness:

  • We drive the development of submission-compliant deliverables.

  • Facilitate streamlined regulatory queries and accelerated responses.


The Accenture data standards consultants play a significant role in helping define and develop the widely recognized standards developed by the Clinical Data Interchange Standards Consortium (CDISC). Our domain knowledge is built on practical experience developing and implementing CDISC models and front-line participation and leadership on major CDISC related activities.

  • Our data standards professionals have authored and contributed to the development of more than 20 CDISC standards.

  • Accenture is a CDISC corporate sponsor and a CDISC Registered Solutions Provider with 11 years of experience converting 20,000 domains for over 1,000 studies.

  • Accenture is a certified CDISC trainer and has trained FDA reviewers in the use of the CDISC Study Data Tabulation Model (SDTM).

Clinical Data Management

Starting at the earliest phase of clinical trial execution and through to regulatory submission, our clinical data management professionals leverage their extensive therapeutic experience to support:

  • Authoring of clinical data management plans

  • Unique CRF creation based upon CDASH

  • Database design including edit checks

  • Review of CRFs

  • Vendor data reconciliation

  • Adverse Event and Concomitant medication coding

  • Database lock including final deliverables

We deliver timely and cost effective services during study execution as well as high quality data and analysis. All of the clinical deliverables, from CRF to submission packages are aligned with FDA expectations for the use of clinical data standards as well as electronic submission-readiness. The extensive body of work of our clinical data management professionals includes:

  • Reviewed over 6.5 million case report forms

  • Set up over 2,000 clinical databases

  • Skills in multiple EDC systems including Medidata Rave, Medrio and Oracle InForm


To assist our clients in the adoption of a standards-based, metadata-driven clinical lifecycle, our data standards professionals provide comprehensive consulting services including: CDISC standards governance and roadmap development, standardized data programs to support regulatory submissions, clinical information architecture process design, and customized training programs on CDISC standards.

Accenture professionals integrate the strategic, design, and operational aspects of a standardized data program, addressing the critical areas of people, process and technology. Our proprietary methods and tools support the execution of processes with built-in support for standardization. Sponsor organizations rely on our experience and knowledge to develop a long-term standards implementation strategy, phasing in the support of CDISC standards across critical business units. Our team has made long-term, significant contributions to CDISC standards and has regular interactions with the FDA in the scope of its activities:

  • Our data standards professionals have authored and contributed to the development of more than 20 CDISC standards.

  • Accenture is a CDISC corporate sponsor and a CDISC Registered Solutions Provider with 11 years of experience converting 20,000 domains for over 1,000 studies.


Through all phases of clinical trial execution, our clinical programmers and statisticians produce high-quality submission-compliant deliverables including analysis datasets (ADaM), tables, listing and figures (TLFs). Our biostatistical services include the preparation of statistical analysis plans (SAPs), clinical development plans, statistical sections of clinical study reports, and assistance in Data Monitoring Committee (DMC) activities.

Our programming and statistical teams closely collaborate in delivering the analysis and presentation of clinical trial data, whether it is for a single study or to support integrated summaries of safety and or efficacy (ISS/ISE) included in global drug applications. Drawing on extensive technical knowledge and industry-leading CDISC standards expertise, our track record includes the creation of over 40,000 TLFs.


In the latter stages of clinical trial execution, we work with our clients to enhance the submission-readiness of their clinical study assets. We provide:

  • Legacy and in-stream data conversion and creation of publishing documents (define.xml Reviewer’s Guide)

  • Up-versioning services

  • SDTM domains and publishing document validation

  • Development of SDTM compliant pooled databases for ISS/ISE analysis

  • Clinical data asset review services to support FDA submission strategy

  • Clinical data warehouse design and creation

Our extensive global clinical data team has experience in over 26 therapeutic areas.

Accenture professionals harness their deep understanding of the principles of CDISC models to deliver technically-sound solutions that make a measurable impact on the analysis and regulatory review phases of the clinical data lifecycle. We evaluate all inputs to the process to ensure the delivery of the appropriate solution from the start.

In the 11 years that we have provided SDTM domain generation capabilities, we have built a world-class, scalable solution. Our track record includes:

  • Over 1,000 studies mapped to SDTM

  • Delivery of over 80 SDTM-based submissions to the FDA

  • Converted more than 300 studies to SDTM for the FDA and provided consulting services on custom domain creation.