Application Notes & Case Studies

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Getting Creative: A Hybrid Answer When The Conventional Won’t Do 3/2/2020

    A small oncology-focused biotech company presented such a challenge when seeking to contract out its data management services. This CRO combined outsourcing, insourcing, and geographic flexibility to devise a hybrid solution.

  8. A High Unmet Need That No One Wanted To Talk About 3/2/2020

    What do you do when patients are too embarrassed to talk about what’s wrong with them? Recruiting “hidden” patient groups for rare disease studies is always challenging, and flexibility is the only constant.

  9. Clinical Development Challenge - Use Of RWA To Understand Natural History 2/26/2020

    A biotechnology company without an in-house real-world evidence team did not have the adequate resources, connections, or expertise available to conduct a natural history study of the rare, oncology indication for which they were developing a new therapy. Their solution was found in a virtual real-world evidence department.

  10. Clinical Trial Start To Finish …. That Was Easy 2/26/2020

    A sponsor needed to test a new nonsteroidal anti-inflammatory drug (NSAID). Working with an experienced CRO allowed them to line up the 40 best sites in the country for this type of analgesia study and have the best training and tools at each site.