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
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:
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.
CRO and Site Agreements for Phase 4 Clinical Study of Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World
CRO and Site Agreements for a Phase 3 Clinical Study of Betrixaban with over 180 Sites in 34 Countries
CRO and Site Agreements for an Open-Label, Phase 2 Study with 30 Sites in 9 Countries exploring the efficiency of Neratinib on Patients with Solid Tumors with Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations Or EGFR Gene Amplification
CRO and Site Agreements for a BGB-3111-302 Phase 3 Global Trial with 60 Sites in 12 Countries
Clinical Trial Agreements Contracting support for clinical trials 2036-01-004, 2618-01-001, 2618-03-002 Intrigue, 3014-01-001, 2036-01-003 & 2618-03-001 InvictusWebsite
Contracting support for clinical trials BLU-285-1303, BLU-285-2203 and BLU-285-2202Website
CRO and Site Agreements for a pivotal device study with 15 US sites to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC (Barcelona clinic liver cancer (BCLC) stage A, BCLC stage B1 and BCLC stage B2)
CRO and Site Agreements for a Phase I Study to evaluate the safety, pharmacokinetics, and pharmacodynamics of escalating doses of IDE397 (MAT2A inhibitor) in patients with advanced solid tumors
CRO and Site Agreements for a randomized multi-center, parallel-group study to evaluate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared with standard of care transcatheter arterial embolization (TAE)/transcatheter arterial chemoembolization (cTACE)
Contracting support for a global, multicenter, randomized, placebo-controlled Phase 3 Trial to compare the efficacy and safety of Fruquintinib plus best supportive care to placebo plus best supportive care in patients with refractory metastatic colorectal cancer (FRESCO-2)