Clinical Leader Newsletter: The Keys To Effective Strategic Partnerships

Improve Clinical Sites By Bringing Together Pharma, Biomedical R&D, And CROs By Ed Miseta, Chief Editor, Clinical Leader How do you take pharma, and other biomedical R&D, as well as CROs, which for years have operated as separate entities, and get them to come together and create standards and an accreditation process to benefit the entire industry, indeed, the entire enterprise of a complex of multiple stakeholders, including regulators and the public? Featured Articles "Everyone's Risk, Everyone's Benefit": The Keys To Effective Strategic Partnerships   By Anna Rose Welch, Associate Editor, Clinical Leader Whether it be a collaboration between Big Pharma companies, a sponsor and CRO, or a pharma company and a research foundation, partnerships are dependent on the proper alignment of goals, trust, and risk management. As the industry is faced with increasing demand for timely drug research and development, partnerships need to be a balance of equals, and both parties need to be ready to tackle whatever challenges might arise. Electronic Informed Consent: Considerations For Implementation In Clinical Trials By Miguel Orri, InnovatOrri Pharma Consulting Ltd In an era where data acquisition (e.g., ePRO), capture (EDC), and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process. Spotlight On The TMF Reference Model   By Sharon Ames, Enterprise Program Director, NextDocs The Trial Master File Reference Model (TMF RM), a supported initiative of the Drug Information Association’s (DIA) Document and Records Management Community, is a collaborative reference for the contents of a TMF. Harnessing Public Involvement For Faster, Lower-Cost Trials In Dementia By Kevin Craig, Senior Medical Director, Neuroscience Medical and Scientific Services, Clinical Development Services, Covance Inc. There should be no doubt that clinical trials in Alzheimer’s disease and dementia need to be faster and more cost-effective if new treatments are to reach patients. Why Move Your Trial From Paper To The Cloud By Aaron Mazze, Merge eClinical The popularity of EDC (electronic data capture) continues to grow throughout the clinical research sector. At the same time, though, a number of small sponsors and clinical research organizations (CROs) believe EDC is still beyond their budgets and continue to enter paper case report forms (CRFs) into electronic databases (double data entry). Most Popular News • ERT To Acquire PHT Corporation Subscribe Today   For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine