When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.
It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.
Recent acquisitions have convinced Mark Weinstein, CEO of BioClinica, that his company is ready to work with the largest of pharmaceutical companies, be they CRO or drug sponsor. Bio-Imaging, which officially became BioClinica in 2009 following a major merger, is currently running over 400 imaging studies with over 200 clients. Weinstein notes a series of well-planned steps were required to get them to this position.
In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. By Bart Cobert
Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.
Electronic Data Capture (EDC) refers to the collection of medical data for patients enrolled in clinical trials. The most common mechanism is for staff at the investigative site to enter the data into a web-based interface, and for staff at the sponsor company to monitor the data using the same interface but with different security permissions. By Keith Howells
Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.
The purpose of this whitepaper is to define a Rescue Study, outline the basic assumptions, including risks, in setting up such a trial based on DATATRAK’s prior experiences, and present the actions that can help avoid or mitigate these risks during a deployment.
BioClinica, Inc. a global provider of clinical trial management solutions, recently announced that members of its team will attend, participate in, and speak at several upcoming industry conferences in April, May, and June.
DiaMedica (TSX VENTURE:DMA) has successfully completed cGMP manufacturing of DM-199 to be utilized in upcoming clinical trials.
ERT, a global technology-driven provider of health outcomes research services to biopharmaceutical organizations, medical device companies and contract research organizations (CROs), recently announced significant milestones that reinforce its position as a leading eClinical trial solutions provider in Japan.
Spaulding Clinical Research Announces Collaboration with Blinded Diagnostics for centralized cardiac safety services for select pharmaceutical clients.
Spaulding Clinical Research has agreed to offer ECG services using the new Spaulding webECG Diagnostic ECG Management system for late stage clinical trials through Blinded Diagnostics.
ERT, a global technology-driven provider of health outcomes services to biopharmaceutical organizations, medical device companies and contract research organizations (CROs), recently announced the launch of an enhanced clinical research workflow technology designed to streamline data collection, analysis and processing in clinical trials.
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Phase 3 trial evaluating Nexavar® (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival.
iCardiac Technologies, Inc., a provider of next generation cardiac core lab services, announced recently it has recorded another increase in its growth rate.