Where smart research goes to work.

Quality and Compliance

Maximum transparency, data integrity, cross-validation - it’s all here at your fingertips in eCOS.

The Top Line

  1. Safe Harbor and ISO-certified, 21CFR Part 11 adherence
  2. Fully support all GCP and associated regulations
  3. Advanced tools such as the V-Room (a Virtual Audit) control costs

FISMA. 21CFR. MedDRA. OHRP. ISO. The acronyms dominating clinical research are enough to make eyes glaze, heads ache, and sometimes, jaws drop. 

And yet, it’s the world we live in every day. That’s why eClinicalOS (eCOS) supports the full range of regulatory guidelines you need and expect to help your study sail successfully through the “Ocean of Jargon.” 

What We Support What We Follow
21CFR Part 11
21CFR Part 50
21CFR Part 54
21CFR Part 312
21CFR Part 314
21CFR Part 820
45CFR Parts 160, 162, 164
EU GMP Annex 11
FDA Guidance - Investigator Responsibility
ICH E2A, ICH E3, ICH E6, ICH E8, ICH E9, ICH E2D, ICH E14
OHRP
21CFR Part 11
EU GMP Annex 11
45CFR Parts 160, 162, 164
21CFR Part 820
FDA Guidance - Computerized Systems Used in Clinical Investigations
FDA Guidance - General Principles of Software Validation
Local, State Regulations

Over and Above

In addition to the standard capabilities you’ll find in other systems, eCOS offers a series of unique advanced capabilities that strengthen the platform and take your Quality Assurance and Compliance programs to a whole new level. For example, our V-Room gives you full control of the internal audit process right from your eCOS dashboard. This “Virtual Audit Room” lets you direct every aspect of the testing process to ensure the study follows ALCOA principles. Our team of experts also is available to conduct on-site audits to resolve any issues that might crop up.

Built-in Features:

eCOS has two built-in features to support your study: a Vendor Qualification Audit and a Study Audit.

Vendor Qualification Audit

The first step on the road to compliance involves ensuring all your ducks not only are in a row, but that they’re the most-qualified ducks for the task at hand. Our vendor audit process helps you guarantee all vendors meet Good Clinical Practice standards from the get-go, so you never get a phone call that starts, “Houston, we have a problem.” 

Study Audit

When you get down to it, quality assurance in clinical research is about minimizing risk. It means identifying and eliminating potential problems before a study goes live by ensuring every process adheres strictly to all pertinent regulations across devices, procedures and all points in between. Most important, it means the answer to “Will this study pass an audit?” is never “Um, let’s hope so.” 

Study Audit in eCOS helps you examine every detail of your study. At any point, you can tap this feature to review the work to date and identify any anomalies or concerns so you can address them rapidly. In addition, we built supporting tools right into the eCOS platform that allow you to audit the study-specific deliverables.

What does this intense, consistent focus on quality and consistency mean for you? We can sum it up in three new acronyms we suggest adding to your lexicon: FCFY*, REDIDO** and YCRN***.

* Fewer Concerns For You.
** Reduced Exposure Day-In and Day-Out.

*** You Can Relax Now.

 

ecos_circle_transSpeak with an expert.

For more information about our Quality, Compliance and Audit Services, please contact Anu Virkar.