This case study describes a Phase III clinical trial study that needed to overcome several enrollment challenges in order to be successful. These challenges included a general unawareness of the disease the trial focused on, a lack of referral networks for sites not affiliated with the hospitals in the study, a lack of site commitment, and long-term patient commitments that included multiple surveillance follow ups.
A leading biotechnology firm with a reputation for delivering quality solutions was tasked with conducting a groundbreaking multicenter study evaluating the safety and efficacy of a new oncology drug in patients with pancreatic cancer.
Time is always of the essence in clinical trials. But when competitors have the lead in bringing an alternative therapy to market, “the need for speed” takes on a whole new focus. This was the case with one top tier global pharmaceutical company that was just beginning its development programme for several infectious disease indications. Meanwhile, competitors for one of the compound’s primary indications were further along the regulatory pathway. Could Almac help the trial sponsor close the gap through technology to better manage patients, clinical supplies, and trial data?
I recently had the privilege of attending the NextLevel Medical Affairs Leaders Forum in London, and chairing the special session for medical device professionals. Overall, the conference was fantastic and a great opportunity for collaboration of like-minds. In particular, the medical device session was ripe with new perceptions on how best to navigate our changing regulatory environment.
Certainly, every sponsor wants to minimize wastage in clinical trial supplies, but the motivation to do so is extraordinary when the product under study is unusually expensive. A top-tier, international pharmaceutical company engaged Almac to ensure that it did not incur undue drug supply costs for a global study involving a very expensive investigational product. With some ingenuity and customizations to the IXRS® platform for managing patients, supplies, and trial data, Almac helped the client re-envision its study design and supply strategy.
Covance was approached by a European client that was considering the acquisition of an early-stage ovarian cancer therapy product.
A double blind, placebo controlled, parallel group, randomized study to evaluate the safety, tolerability, and efficacy of a novel, orally available small molecule for treatment of pain in osteoarthritis (OA).
PRA Health Sciences performed data management activities for this project while the client was responsible for all other services, including site monitoring. When the client reduced the timelines for database lock by approximately 9 months, PRA immediately created a detailed closure plan, listing all tasks and activities that required completion within the given timelines. This plan was reviewed and approved by all parties involved. To successfully complete the closeout period, PRA calculated data flows and trained additional staff members.
In 2005, Abbott sanctioned an executive-sponsored governance body to drive the development and implementation of enterprise-wide study build, data capture and trial management processes using a single electronic data capture (EDC) vendor for all clinical studies. The objective was to quickly move the lion’s share of studies to electronic capture means while maximizing site acceptance.
CTI Clinical Trial & Consulting Services, a full-service global contract research organization (CRO) specializing in complex therapeutic areas, adopted the Medidata Clinical Cloud® as its preferred platform of clinical trial technology to efficiently run the operations of its rapidly growing global business. The company has been using Medidata’s cloud-based platform for over three years.
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