A specialized biopharmaceutical company had a breakthrough therapy that had the potential to be first-in-class for a rare and aggressive hematological cancer and had shown great potential in earlier clinical trial. In many breakthrough treatment areas, where the patient population is small, or there is overwhelming evidence of efficacy at Phase 2, it has become common for drugs to be approved based on a pivotal single arm trial – however, this is not always optimal. Read how synthetic control offers a practical, effective way to leverage real-world evidence and has been applied in regulatory approvals.
A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.
Some clinical trials face numerous and critical complexities which increase pressure and risk for the success of the trial. This case study, highlights the complexities faced by one sponsor that were compounded by rigid timeframes, comparator sourcing availability, sensitized drug product and intricate kit design. By partnering with Almac, the sponsor was able to harness Almac’s expertise in project management and comparator sourcing to deliver multiple shipments to sites and depots on time and within specified conditions.
The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.
The most successful clinical trials have one thing in common: sponsors never stop looking for ways to improve processes that support the core objective of delivering safe, compliant investigational product to patients, when and where they need it. Read Almac’s latest case study to learn how they helped one sponsor effectively manage a drug formulation change mid-trial without study interruptions or patient impact.
Midlantic Urology Associates had been employing a single driver for all participant pick-ups. This proved to be inefficient and unsustainable, so they began utilizing taxis. This alternative was costly and unreliable – there had to be a better way. ClinCard’s integration with Lyft has not only improved the experience for patients and study coordinators but has also helped with recruitment as new patients are enrolling in the study as a result of this added convenience.
Concern ensued across the Medical University of South Carolina (MUSC) research faculty and staff when they received notice that departments would need to somehow track and sum all their petty cash, Walmart and Target gift cards, VISA cards and checks issued through Accounts Payable (as there was no institutional research policy standardizing a single type of remuneration payment for clinical research participants). A fellow academic medical school recommended ClinCard by Greenphire which ended up being the perfect solution.
Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources. Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited.
Merck has embarked on a company-wide mission to update its TMF processes and technology to ensure greater quality documentation and timeliness, while making it easier for study personnel to reach critical milestones.
Learn how IQVIA Biotech helped a biotechnology company reach critical milestones as it prepared to launch an international Phase III clinical trial for its investigational ALK inhibitor in patients with non-small cell lung cancer.
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