Oramed Pharmaceuticals hopes to make oral delivery of medicines a reality for all patients. The company is focused on taking many treatments that have only been available via intravenous injections and making them available to patients via oral dosage.
Commercial success in the pharmaceutical industry requires that clinical programs, in addition to demonstrating clinical effectiveness, also provide data supporting a drug’s value. The Institute for Clinical and Economic Research (ICER), a U.S.-based cost-effectiveness watchdog, recently released an analysis suggesting that Vertex Pharmaceuticals’ cystic fibrosis (CF) franchise — Kalydeco, Orkambi, and the recently launched Symdeko — while offering meaningful clinical efficacy, would require discounts of approximately 70 percent1 to be cost-effective.
Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?
Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.
Learn how by embracing a systematic, data-driven approach, it is possible for metrics to identify more accurately the best sites, steps causing delays, the associated costs, and why this is happening.
Learn about how sites struggling under the weight of too much technology, yet looking for a more robust collaboration and transparency process can benefit from automated workflows in the initiation of clinical trials.
This whitepaper offers a résumé of regulations under which eConsent solutions and vendors may fall and, more importantly, discusses the practical implications of those regulations for vendors and those responsible for designing and executing research plans.
Current MRD detection landscape, key considerations for each approach, and current advancements that will contribute to further improvements in MRD detection.
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These guidance documents should provide greater reassurance to digital product developers about how and when FDA will classify and regulate their products.
Pharma companies and CROs are recognizing the need for focused electronic feasibility solutions to resolve challenges with processes managed in Excel trackers.
Overcoming the many known barriers to adopting and implementing an RBM program.
What can you do during your study to maximize your chances of success when it comes time to submit?
As more and more sites adopt eSource, the industry is poised for swift change and dramatic growth.