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French safety authority confirms what had been speculated--Phase I volunteers received the fifth of the highest dose escalation of the investigational drug at the same time, which goes against EMA recommendations.

Oracle will participate as a Global Impact Partner (GIP) and will participate on the SCRS Global Impact Board at an executive level, and work closely with SCRS’ Leadership Council to determine strategic initiatives for SCRS.

Bioclinica has built a post-approval study-specific technology platform along with a Program Coordinating Center (PCC) with dedicated and experienced post-approval research staff.

The alliance’s primary goal is to be flexible and adaptive based on client needs, while mitigating client risk, driving efficiency and improving timelines, and removing barriers that prevent getting treatments to market in a timely fashion.

In addition to the patient education database, guidelines for the interaction of patient organizations with ethics, health technology assessment, regulatory bodies and industry are being developed with the goal of being released later in the year.

Gather™ is an integrated technology system that can be accessed through any internet-connected device and uses a module-based product suite.

New approaches include using Big Data to identify and understand patient populations, engaging the “voice of the patient” in trial design, and using new technologies and social media to reach, attract, and keep patients.

Clinerion will present its Patient Recruitment System (PRS), which allows real-time patient search for clinical trials via direct query of electronic health records.

FDA will provide expert scientific, clinical and statistical input to guide the further enhancement of CCDA to support FDA reviewers in rapidly detecting and investigating safety signals during new drug application (NDA) reviews and post-market pharmacovigilance activities.

The second phase of this global collaborative platform includes initial roll-out of a federated trust framework for secure enterprise-wide identity management and single sign-on access to multiple end-user applications.

Medidata's ClinicalCloud will provide scalable technology to Celltrion's biosimilars development programs.

The alliance will offer hybrid studies that combine existing data from electronic health records (EHRs) and medical claims (from Optum) with global, site-based clinical research (Parexel).

The Veeva TMF Maturity Model is available as a self-service online tool or as a more detailed, in-person evaluation with a subject matter expert.

The solution will ‘hand-hold’ companies through the process of performing a protocol risk assessment and developing resulting quality risk management plan.