Application Notes & Case Studies

1. Infectious Disease Teams 4/2/2020

   A not-for-profit Sponsor requested assistance with monitoring in an Ebola hot spot at trial naïve sites with little experience. Ultimately, the study required rapidly deploying solutions across diverse geographies. Read how the quick response and the geographic alignment of the team enabled the study to be completed.

2. Comparative Analysis For Non-IND Sites 4/1/2020

   A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
   coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

    

3. From KOLs To Patient Advocates, UsingEvery Tool To Fight A Rare Disease 3/11/2020

   With a recruiting target of 18 patients for a condition that afflicts just one in 31,000 people this CRO had to make full use of what few resources were avaiable. By working with KOLs and a patient advocacy group they located their 18 patients ahead of schedule and completed the 26-week trial early.

4. Vertex Data Management Team Cuts EDC System Build Times By Half With Veeva Vault CDMS 3/6/2020

   Read how Vertex Pharmaceuticals, Inc. reduced EDC database build times from 13-14 weeks for early phase studies to under 7.5 weeks today.

5. Advanced Clinical Achieves A Strategic Advantage With Veeva Vault eTMF 3/6/2020

   Contract research organization Advanced Clinical leverages Veeva Vault eTMF to run faster, higher-quality trials for study partners.

6. Insmed’s Fast And Successful EDC Study Builds With Veeva Vault CDMS 3/6/2020

   Insmed describes the critical success factors enabling them to incorporate significant protocol changes and still hit their FPI deadline with Vault EDC.

7. A CRO’s Road To ePRO Revenue 3/6/2020

   A global, full-service CRO had looked at the increasing demand and expected growth rates for electronic patient reported outcome (ePRO) technology and determined that the opportunity for an ePRO offering would be significant. This case study describes how a global CRO successfully added ePRO to its service offerings enabling them to provide a unified service to its sponsor clients while creating a new revenue stream for themselves.

8. Adopting Label Change Best Practice To Promote Clarity And Compliance 3/5/2020

   Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.

9. Cleaning Up Patient Data … Quickly 3/2/2020

   A sponsor needed to deliver data so a go-/no-go decision could be made at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat impersonal CRO and a small sponsor that was used to close personal relationships and more or less constant interaction with the team managing its studies. We picked up the project in March 2013 and completed data lock by the end of September.

10. Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice 3/2/2020

    Investigative sites performing studies on behalf of pharma companies often operate on tight profit margins and need to get paid on time. This Top 10 pharmaceutical company understood that becoming the sponsor of choice for sites around the world was a competitive differentiator.