Oct 29 | eClin | Vendor Contributed Comment | 2012 has been a bumpy ride for pharmaceutical firms, exacerbated by a significant loss of revenue related to drug patent expirations. It’s been estimated that drugs scheduled to go off patent this year represent over $30 billion in sales. A wealth of new tools and technological advancements may be the answer for how researchers can discover new, life-saving therapies more quickly while simultaneously cutting costs. One development that is generating a lot of industry buzz is the integration of electronic data capture (EDC) platforms, traditionally used to manage clinical trials, with those used within the health care industry to create and maintain electronic health records (EHR).   

Oct 1 | News Brief | WorldCare Clinical (WCC) has announced its new Endpoint Assessment Committee (EAC) services for blinded independent central review of clinical trial data. WCC’s EAC services include expert assessments by physicians drawn from multiple therapeutic areas for comprehensive efficacy and safety reviews.

Sep 24 | eCliniqua | Medidata Solutions has deployed Opscode Hosted Chef to automate its hybrid infrastructure for clinical development: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, to clinical data capture and management, safety events capture, medical coding, and business analytics. 

Sep 20 | eCliniqua | A special one-day conference next month will showcase many of the leading figures in the emerging field of adaptive trial designs, with a view to helping organizations recognize their benefits and understand the keys to successful implementation.

Sep 13 | eCliniqua Exclusive | EDC purist Isis Pharmaceuticals is stepping up its partnering activity with BioClinica, Inc. to include larger and more complex clinical trials within its expansive antisense drug development program. Up to 20 new trials are on the docket for next year, including several phase III studies involving thousands of participants.  

Sep 11 | Guest Commentary | Regulators are paying increased attention to sponsors within the realm of vendor oversight. Clinical Trial Sponsors must include vendor oversight in any assessment of inspection readiness on their mid-stage development programs, and once the gaps have been identified, apply preventative actions across all outsourced programs in development.