Clinical Trials Transformation Initiative (CTTI)

At its most fundamental level, the Clinical Trials Transformation Initiative (CTTI) is a group of individuals and organizations who want to improve the quality and efficiency of clinical trials. It was co-founded by Duke University and the U.S. Food and Drug Administration in 2007 in an effort to identify and address challenges to well-designed, properly executed clinical trials, and offer recommendations to improve and modernize research.

JANA Life Sciences

JANA Life Sciences is a division of JANA, Inc., founded in 1973 to provide best-in-class authoring, engineering and technical solutions. We serve some of the world’s largest corporations, and our multi-industry exposure gives us insight into the best practices in use today. Focusing on our customers’ short-term and long-term needs, we provide high quality services that are customizable, fairly priced and delivered on time — that’s “The JANA Way.”

Sage Submissions

Sage Submissions provides Sage Templates to enable the use of MS Word to author the content of regulatory submissions for eCTD and eCopy formats. Sage Templates were developed to be compliant with the PDF specifications for these electronic submission formats, and to enable authors to quickly and accurately write the content of their submission documents.

5th Port

5thPort™ is a cloud-based patient engagement and eConsent solution built specifically for clinical trials. It is purposefully designed to tackle four primary challenges in both site-based and decentralized clinical trials: reduce your patient drop-out rates, improve your patient conversion rates, enhance patient protocol adherence, simplify your consent related audit and regulatory compliance process.

eSubmissions University

eSubmissions University provides adult learners with accessible, reasonably priced, training and education on electronic submissions that are destined for and/or filed with the United States Food and Drug Administration (FDA). eSubmissions University is exclusively dedicated to providing electronic submissions education for:

• Employees of small businesses, sole proprietors or consultants,

• Employees of a university, college, or not-for-profit research center/institution,

• Employees of contract research organizations serving small businesses, and/or

• Any person/company subject to the FDA's electronic submission requirements.

The goal of eSubmissions University, is to provide reasonably priced, high-quality training and education to meet FDA requirements for electronic submissions.

PRONAV CLINICAL

PROMAP Clinical is our proprietary document workflow platform. Via a shared cloud-based portal spanning all the partners in the supply chain, it supports the transfer, storage, review and approval of all supply chain documentation including: Manufacturing Site Audit reports, Qualified Person Declaration of GMP Compliance, Investigational Medicinal Product Dossiers, Clinical Trial Approvals, Artwork Specifications and Label-copy, Copies of Master and Executed Batch Records, Certificates of Analysis / Compliance, Shipping Documentation, Temperature Data Records.