Application Notes & Case Studies

1. Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry 1/12/2021

   A global top-ten pharmaceutical company was sponsoring a complex, 8-year Phase III trial across 43 countries. The Sponsor was under intense pressure to reduce trial costs and leverage internal resources. Ultimately, study sites began to run out of medication. They realized that the trial could be better managed if it was outsourced. 

2. Rho’s Approach To Overcoming Enrollment Challenges In A CNS Trial 1/7/2021

   A mid-sized biotech company running a randomized, doubleblind, placebo controlled (1:1) Phase 3 CNS pain study, with a single treatment administration, had achieved ex-US approval yet faced significant enrollment challenges when a modified version of the study was implemented in the US. With a goal of 300 participants, the rate of enrollment sat at a mere 0.5 subjects a month. The best laid plans weren’t cutting it.

3. Conclusive & Positive Results Delivered Ahead Of Time – By Eight Months 12/22/2020

   Most patients with Binge Eating Disorder (BED) seek help from psychiatrists, nutritionists, or obesity specialists, but there was no approved, effective pharmacologic treatment. With unanticipated interest in pivotal Phase 3 studies, we needed to line up and train the right resources while collaborating effectively with the central laboratory, data manager, and other participants.

4. Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track 12/7/2020

   Retrophin is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.

5. Proactive Strategies For Meeting NDA Timelines Despite Last Minute Supplemental Study Requests 11/3/2020

   With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug.  Having a CRO that is experienced in the common FDA-required studies for NDA submission can make or break the submission timeline. Nimble responses and expert logistics setups can make all the difference.

6. How a Best-Practice Strategy For Sourcing Ancillary Materials Reduced Risk, Spending and Workload In A Global Diabetes Trial 10/29/2020

   It’s impossible to run a global clinical trial of an investigational diabetes drug without ancillary materials. And as one leading multi-national pharmaceutical company recently learned, managing ancillaries can be a challenge every bit as complex as the trial itself.

7. The Michael J. Fox Foundation For Parkinson’s Research Works With Service Provider To Remove Reimbursement And Travel Obstacles For Clinical Study Participants 10/19/2020

   In 2010, MJFF launched a large-scale clinical study conducted at a network of clinical sites around the world focused on identifying and validating Parkinson’s disease biomarkers. The study realized it needed a new way to ensure that participants were remaining engaged throughout the long protocol and that the experience was as seamless as possible for both the volunteers and the site coordinators. They were able to source a solution to support patient-centricity, as well as study site efficiency.

8. Delivering Clinical Trial Medications Direct-To-Patient 10/15/2020

   In a perfect world, patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately, that is not always the case. In recent years, the direct-to- patient model, which brings medical procedures to a patient’s home, has emerged as a solution for sponsors to increase patient recruitment and retention in clinical trials.

9. Reinventing Neurodegenerative Protocols To Overcome COVID-19 Hurdles 10/13/2020

   A global, pivotal Phase III Alzheimer’s trial aiming to screen 6,000+ patients faced unforeseen challenges when the COVID-19 pandemic hit just a few months into recruitment. Finding a solution that provided proactive screening, assessment, and IP administration techniques enabled a new approach to collecting patient data and administering required IP and study visits which preserved the study integrity.

10. Global Pharma Company Dramatically Improves Collaboration, Communication, And Compliance In Trials 10/9/2020

    A Top 5 global pharmaceutical company wanted to help sites do everyday tasks more efficiently, making it easier for site staff to adhere to the protocol and deliver high-quality data. After evaluations and pilots, the company deployed IQVIA Technologies’ Investigator Site Portal (formerly DrugDev) in a 4-phase approach that delivered benefits each step of the way.