Biotech

Clinical Trials Management for Biotechnology Companies

Fledgling biotechnology and start-up companies face different challenges than established pharmaceutical companies. Their reality mandates a different way of thinking and doing, a more "Thinking-Out-Of-The-Box" approach.

Throughout years of experience, we at TransCom have developed tools and infrastructure that are specifically designed to support biotechnology and start-up companies in successful implementation of clinical development stages from Phase I to Phase II and from Phase II to Phase III.

Why Should Biotechnology Companies Choose TransCom?

• More than a decade of experience in managing clinical trials for biotechnology and start-up companies.
• We have the knowledge and experience required to lead and assist our clients in successfully overcoming the early clinical development stages, from Phase I studies to late-phase studies.
• We understand that clinical trials for fledgling biotechnology and start-up companies must be managed in a way that may be radically different than the traditional big pharma way.
• We work in close cooperation with top world-renown medical and regulatory consultants who assist our clients throughout the FDA negotiation process.
• We adapt our internal processes to our clients' needs, instead of adapting the client to our internal processes.

Our Special Approach for Fledging Biotechnology Companies

 TransCom works in close cooperation with start-ups right from the start, offering:

• Strategic consulting for protocol development
• Protocol writing and supervision
• Selection of medical consultants
• Selection of investigators and clinical sites
• Preparation of submission packages and communication with ethics committees and regulatory authorities
• Informed Consent Form and Patient Information Sheet (ICF and PIS) design
• Case Report Form (CRF) design
• Patient Diaries and other Patient Reported Outcome (PRO) design
• Study documentation design
• Budget and contract negotiations with sites
• Import and distribution of investigational products to sites
• Identification and selection of sub-contractors (central labs, statistics and database managers, study coordinators, etc.)
• Clinical site management and monitoring

TransCom supports clients throughout the entire clinical development stage by characterizing and identifying the client's needs in order to maximize the success of this stage.