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 pressure to get the contracting right for clinical trials is substantial. You want to sign up sites and begin enrollment as quickly as possible. But you need to negotiate agreements that manage risk, protect intellectual property, meet requirements for regulatory submissions, and comply with third party development agreements. You’re concerned that CROs may not handle your contracting with the care and accuracy of a law firm.
At Faber, our integrated team of lawyers and contracts specialists have helped our clients launch hundreds of clinical trials, and collectively they’ve worked on over 10,000 CTAs. We can leverage this experience to guide you through a contracting process that’s tailored to your project. We’ll factor in:
Based on an in-depth understanding of your situation, we can deliver a full range of clinical trial contract services, including:
Major pharmaceutical and biotech firms have in-house contracts specialists and attorneys to manage the complexities of this contracting process. Emerging companies without this infrastructure have few options.
Our process is unique among law firms. Experienced contract specialists work alongside attorneys steeped in the business side of life sciences. Prior to joining our firm, team members have held full-time positions with hospitals, biotech and pharmaceutical companies, and contract research organizations (CROs). Collectively, they have worked on tens of thousands of clinical trial agreements worldwide.
We view ourselves as more than operational expeditors. Instead, we’re advisors, who understand the need to balance speed with attention to the details that could derail your project. Based on your trial protocol, site selection criteria and the capabilities of the CRO of your choice, we’ll identify key issues, then tailor a contracting strategy that:
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 – to expedite negotiations and help you enroll your trial sooner.
We’ll handle the master agreement with your CRO, then negotiate directly with each trial location. Chances are we’ve recently worked with the sites you’re interested in, which can further accelerate discussions.
Learn more about our approach, which is modeled on the practices of major pharmaceutical companies and is unique among law firms. Or contact us now to learn how we can bring contracting best practices to your clinical trial.
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 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)
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 2 Study with 23 Sites in 8 Countries of PRM-151 in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocyt
CRO and Site Agreements for Global Phase 3 Clinical Study Of Neratinib (HKI-272)
CRO and Site Agreements for a Phase 2 Trial with 18 Sites in 7 Countries to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
CRO and Site Agreements for Global Phase 3 Multicenter Study BGB-3111 and Ibrutinib
CRO and Site Agreements for a BGB-3111-302 Phase 3 Global Trial with 60 Sites in 12 Countries