Launching a drug development company with novel technology from academia
Our corporate group has worked with hundreds of entrepreneurs at this stage to help them optimally and efficiently select and form the appropriate legal entity
The Faber Difference
Values & Community
Our Clients
Areas of Expertise
Protects control of intellectual property
Preserves access to data
Ensures regulatory compliance
Fairly allocates risk
At Faber, we develop a deep understanding of our pharmaceutical and medical device company clients and their specific clinical studies, and we utilize that knowledge through our client teams of lawyers and contract specialists who:
develop contracting models and document templates tailored for the particular participants, study, and country mix
help our client's structure its relationships with vendors, consultants and contractors so as to manage risk, and build in counterparty accountability mechanisms
bring in, when needed, the expertise of local legal counsel who we have existing relationships with due to previous collaborations in the countries involved in the study
our comprehensive understanding of industry practices, both within geographical regions and within categories of sites (from large academic institutions to smaller private clinics)
our extensive experience working with centralized International Review Boards (IRBs), country and regional ethics committees, scientific advisory boards, Key Opinion Leaders (KOLs), and in consulting relationships
our profound understanding of both the legal issues and the practical concerns involved in starting up a late phase clinical study, including Good Clinical Practices (GCP) concerns, Information Consent Form (ICF) issues, data sharing and privacy issues, protection of confidential information, and intellectual property rights
Standard CRO agreements often include numerous generic provisions that can bog down negotiations. By contrast, we’ll design clinical trial agreements (CTAs) that are streamlined, laser-focused and complete in order to expedite negotiations and help you enroll your trial sooner.
If you are conducting your products clinical trial(s) in collaboration with a strategic partner such as Big Pharma, that strategic partner has likely imposed obligations on you designed to protect intellectual property rights, preserve confidentiality and data privacy, ensure compliance, and address liability. Typically, you will be required to pass these obligations along to your clinical trial vendors and sites. Our licensing lawyers have extensive in-house experience operationalizing these complex license and collaboration agreements with strategic partners in the context of clinical trials.
We can help you understand your obligations, and how to incorporate these kinds of requirements effectively into your services and clinical site agreements in order to help you meet aggressive timelines and manage your legal costs.
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