Mar 8 | News Brief | Continuum Health Partners, the network of five prestigious hospitals and academic medical centers in Manhattan and Brooklyn, including Beth Israel Medical Center and St. Luke’s and Roosevelt Hospitals, has chosen to use IntrinsiQ’s IntelliDose clinical oncology software with eClinicalWorks unified electronic medical record (EMR).

Feb 18 | eCliniqua | BioClinica has partnered with Paragon Solutions to plan a study to assess current industry business challenges and trends facing clinical supply chain management, including: study-drug forecasting, study design, and cost reduction opportunities.

Feb 17 | News Brief | Pegasystems has announced its new Life Sciences Industry Foundation, to help improve compliance efficiency through improved collaboration and automation.

Feb 10 | eCliniqua | BioClinica CEO Mark Weinstein’s career started out at Andersen Consulting before moving to Thomson Healthcare in the early 1990s. He joined Bio-Imaging Technologies in 1997, later rebranding the firm as BioClinica as the company grew and diversified. Weinstein spoke to Bio•IT World chief editor Kevin Davies about his company’s rapid growth in particular and the trends for the eClinical space.

Feb 9 | eCliniqua | It will soon be cheaper to sequence a patient’s entire genome and use software filters to implement genetic testing than to conduct multiple separate tests for specific genes. Notwithstanding unresolved regulatory, legal, reimbursement, physician training, and privacy issues related to whole-genome testing, there remain big bioinformatics issues as well.

Feb 8 | eCliniqua | Since his days as a senior biostatistician at Wyeth, Jerald Schindler has been a vigorous proponent of adaptive trial designs as a means to monitor the effectiveness and improve the efficiency of clinical trials. After a stint on the vendor side at Cytel, Schindler joined Merck in 2007 as VP late-stage clinical development statistics.

Feb 7 | eCliniqua Products | ClearTrial has released version 4 of its “clinical trial operations” software, an update the company calls a “major upgrade” to the software-as-a-service offering.

Feb 7 | eCliniqua | In June of 2010, an industry coalition under the auspices of the Drug Information Association (DIA) published version 1.0 of the Trial Master File Reference Model. The trial master file (TMF) contains those essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements. All sponsors and investigators, as well as those conducting trials in academic research, are required to maintain documentation for each clinical trial. Regulatory guidance, such as ICH E6 section 8, addresses only a sub-set of TMF documents. As a result, until version 1.0 of the Trial Master File Reference Model (TMF RM) was released, no comprehensive common model existed for the TMF.

Feb 4 | eCliniqua | Aris Global, which has been in existence for about 20 years, is best known for its software solutions for safety and pharmacovigilance. Two years ago, the company tapped Sylva Collins to expand its software solutions and services to other areas of eClinical research. Collins has a wealth of eClinical expertise—about a decade ago she introduced electronic data capture (EDC) to Novartis and later had a stint at Kendle, a contract research organization.

Feb 2 | eCliniqua | Mike Wilkinson, CIO and executive vice president at PPD, has a message for pharma: “We’re in this together as partners; we’re not a vendor anymore. I think we need to move away from that kind of transactional approach where all they’re looking for is to have a vendor and buy a service. That’s not going to work in this environment.”