Pre-Clinical to Clinical Transition Consulting

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. 

When a new company is developing a product, the saddle between Pre-clinical and Clinical studies looks sometimes more like an abysm to them.

Throughout years of experience we at TransCom have developed tools and infrastructure that are specifically-designed to support these types of companies in successfully bringing their clinical development stages from the later phases of Pre-clinical to the "First-in-Human/Pivotal studies", Phase II and from Phase II to Phase III.

WHY SHOULD START-UP COMPANIES CHOOSE TRANSCOM TO ACCOMPANY THEM WHILE MOVING TO CLINICAL STAGES?

• More than a decade of experience in accompanying biotechnology, medical device and start-up companies in transitioning from pre-clinical to clinical studies.
• We have the knowledge and experience required to lead and assist our clients in successfully overcoming the transition saddle, from pre-clinical to Phase I studies and on to late-phase studies.
• We understand that clinical trials for fledgling medical device, 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/CE negotiation process.
• We adapt our internal processes to our clients' needs, instead of adapting the client to our internal processes.

OUR SPECIAL APPROACH FOR FLEDGLING START-UP COMPANIES 

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

• Late Pre-clinical studies review and consulting
• 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.