Clinical Trials

Clinical Trials

With R&D costs rising and discovery pipelines delaying, life science organizations are looking for ways to improve operational efficiencies while reducing costs. BMC Group provides pharmaceutical sponsors, medical device companies, and clinical research organizations a secure solution for product development, clinical trials document management support, compliance and regulatory submissions, and licensing strategies.

Physician Reviews and Medical Summaries for Clinical Trials

Clinical trials are completed for a variety of reasons including verifying the effectiveness of intervention to treat a disease, evaluating new drug safety, defining dose administration, testing the drug formulation, exploring combination therapies, and evaluating the effects of therapies on the quality of life. Accurately keeping track of the volumes of medical and laboratory record information is an extraordinary challenge for study physicians and clinical research assistants (CRA).

BMC Group has a team of internist physicians who can competently conduct physician medical reviews and create medical summaries. Furthermore, BMC Group provides a secure, cloud-based platform that allows for a quick and efficient review process. The medical summaries highlight data that is reported on Case Report Forms (CRF), and these summaries are hyperlinked to the underlying medical records. This allows for review of the CRFs and cross-referencing with patient medical history before, during, and throughout the various stages of the study.

Patient Recruitment for Clinical Trials

Patient recruitment for clinical trials is one of the most ethically complicated and challenging campaigns to manage. Patient recruitment involves a highly regulated inclusion/exclusion procedure that educates every participant on the purpose of research, risks and benefits, alternative treatments, and confidentiality of records. Poor patient recruitment is the number one reason that Clinical Trials fail.

BMC Group provides a comprehensive range of patient recruitment campaign services, including:

Clinical Trials Secure Information Management

Clinical trials demand the highest level of information security across the board from CRO intellectual property to patient confidentiality. One of the challenges in maintaining such a level of information security is the wide range of participants in a clinical trial that extend from patients, study physicians, and clinical trials assistants across diverse locations and time zones. In addition, study managers and scientists must collaborate to summarize and verify data, build reportable information, and prepare for FDA, Institutional Review Board (IRB), and regulatory submissions several times throughout the study.

BMC Group provides a secure, collaborative information management platform for storing and sharing confidential information. The platform provides efficient data exchange among team members who can collaboratively review data with full audit and reporting capabilities. Intuitive and easy to use, the platform allows for any number of study stakeholders to upload, review, and manage documents at any given moment.

Fundraising and Licensing

Sponsors and CROs may need to embark on fundraising efforts to successfully kick off clinical trials in order to advance the built pipeline of NCE's and new drug applications. At the end of clinical trials, the sponsors may consider funding from private equity and venture capitalists with an exit strategy that may include licensing rights sale, divestiture, or merger and acquisition. In any of these corporate events, BMC Group facilitates the due diligence process with SmartRoom, a secure virtual data room.