News

Updated employee announcements, business awards and recognition, and company news.

The argument for electronic informed consent as a vital cog in supporting today’s patient-centric push in clinical trials.

The CRO Forum has been asked by TransCelerate to collaborate on reviewing its initiatives. Alan Metz, Forum Chair, and Amy Kissam, Forum Vice-Chair, sit down with Moe Alsumidaie to elaborate on the CRO’s involvement.

The biopharmaceutical industry is starting to adopt TransCelerate’s Risk Assessment Categorization Tool (RACT) in order to identify risks and plan a comprehensive clinical trial risk mitigation strategy. We recently wrote about the RACT moving to the cloud, and the advantages of using such systems. Some of these advantages include the ability for study teams to evaluate R&D portfolio risks by collecting and analyzing RACT data in aggregate.

An new survey conducted by the Association of Clinical Research Organizations (ACRO) has identified wearable technology and an increase in social media use for patient recruitment to be two of the more prevalent technology trends in clinical trials.Read the full release here.

The Clinical Data Interchange Standards Consortium (CDISC) announces the availability of a new standard allowing pharmaceutical companies to register their clinical trials from a single files into regulatory databases of the EMA, FDA and WHO.

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT-a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments-offers expert view on this regulatory change.

FHIR (pronounced "fire") is a new, free of cost, platform that has the ability to access and create data though EHR systems. Wayne Kubick writes that using such a platform could truly re-engineer how pharma collects data during clinical trials.

CRO giant and leading healthcare information provider merge to create a wide-ranging R&D-to-commerical services company, in a deal some contend could trigger a trend of larger CROs adding complementary non-clinical offerings.

Sponsors are paying more attention to the resources and capabilities of CROs when negotiating research contracts and agreements.

Sponsors and their contractors have faced challenges when ensuring that parties involved in global clinical trials adhere to rules and regulations regarding biomedical research. For an effective collaboration to take place, all parties must meet the expectations and accountabilities detailed in the trial contract.

The Innovative Medicines Initiative, a drug research program run by the European Commission and the EFPIA, is inviting bids to run a pilot program regarding preclinical research and development.

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT-a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments-offers expert view on this regulatory change.

Some in the financial industry have argued that we may be in the midst of another economic recession. The biopharmaceutical industry has shown resiliency during such times and industry trends point to that being the case again.