Application Notes & Case Studies

1. Saving Development Time And Economizing Distribution With A Single-Vendor Approach 7/29/2021

   By minimizing the overall time, complexity, and effort of clients’ projects and reducing the risks, Thermo Fisher’s most complete integrated offering represents a strong single-vendor solution.

2. Client-Pharma Partners With World Courier To Expand Its Global Footprint In The U.S. 7/28/2021

   Developing a relationship with a U.S. based sourcing and warehouse leader was a critical element in Client-Pharma's commitment to providing the shortest possible sourcing and logistics supply chain for distributing comparator drugs to U.S. clinical trial sites.

3. Study Start-Up And Enrollment 7/27/2021

   IQVIA Biotech was approached by a clinical-stage biopharmaceutical company to run its Phase II prostate cancer drug trial in the U.S. For more information, download the available case study.

4. Achieving Recruitment Objectives In Dermatology Trial: Reducing Timeline And Cost 7/26/2021

   IQVIA Biotech was selected to help a U.S. biopharmaceutical company examine the safety and efficacy of its investigational therapy for the treatment of moderate-to-severe hidradenitis suppurativa (HS), a chronic skin condition that causes small, but painful lumps under the skin. This case study will highlight IQVIA Biotech’s unique strategies for site selection and centralized recruitment approach to drive enrollment.

5. Using De-Identified Linked Real-World Data To Create An External Control Arm 7/13/2021

   A pharmaceutical company designed its Phase II study of a novel agent to treat metastatic non-small cell lung cancer driven by a rare subtype of EGFR genetic mutation. They needed to construct a control arm that had cohort of patients with the specific subtype of metastatic EGFR non-small cell lung cancer whose disease progressed despite taking platinum-based chemotherapy. By utilizing a platform that allowed them to collect data across three vendors that represented unique patients proved successful and enabled the company to move forwards with the Phase II pivotal trial.

6. Quality Trial Study Design For Phase II For Primary Biliary Cholangitis Improves Enrollment 7/12/2021

   The only widely accepted treatment fro Primary biliary cholangitis (PBC) is Ursodeoxycholic Acid (UDCA), which can delay disease progression and improve long-term survival but does not address the underlying disease. A solution provider drew on their expertise to contribute to the study design and selection of appropriate endpoints for a Phase II trial with a European Pharmaceutical company. Operational teams were then able to focus on data capture and cleaning, leading to safety review assessments, as well as a key Interim analysis, final analysis and clinical study report – all delivered on budget and within required timelines.

7. Phase II Pediatric Study With Selected Metabolic Disorders Aims To Increase Survival Rate 7/12/2021

   A Phase II trial with a U.S. Pharmaceutical company involving pediatric patients with selected inherited metabolic disorders undergoing stem cell transplantation is aiming to magnify the necessary cell population within a Umbilical Cord Blood (UCB) to quicken the time to reach transplant effectiveness and ultimately aims to positively impact the transplant success and survival rate. Partnering with a solution provider on enrollment, supply and medical monitoring is building a path to success.

8. Phase I First-In-Human Study On Wilson Disease Using Gene Therapy 7/12/2021

   A Phase I first in human trial with a European biotechnology company is being initiated using an adeno-associated viral vector (AAV)-based gene therapy. Complex studies such as this have challenges in both the set-up and execution phases, for this study in particular there are challenges to do with a gene therapy in a rare disease, and those revolving around the production, delivery and administration of radiopharmaceutical products as an assessment tool. Innovative solutions enabled sites to take part and to ensure trial is conducted successfully.

9. Global Pharma Saves 4 Months Recruitment Efforts With Digital Campaigning 7/1/2021

   A large global pharma initiated a phase III study testing the efficacy of combining two existing drugs in overactive bladder patients. The study planned to enroll 3,500 patients worldwide a 10-month period across and included sites in multiple countries in the Nordic region. Read how engaging Trialbee from study start to ensured enrollment deadlines were met as planned.

10. Global Biotech Improves Clinical Trial Patient Recruitment With Digital Matching 7/1/2021

    A global biotech initiated a phase III study for severe allergic asthma. Study protocol originally accounted for enrolling 222 patients across nine UK-based investigator sites. After deploying traditional recruitment methods, the sponsor only managed to randomize 20% of the target patient population in 11 months. By partnering with a solution provider they were able to get patient recruitment back on track and meet enrollment targets faster, which would not have been possible with a traditional recruitment approach.