Getting Ready for a Phase 2 or 3 Clinical Trial

Overview
Professionals

Overview

We have provided counsel to hundreds of companies about to conduct multi-country, late-stage clinical studies.

Based on your trial protocol, site selection criteria, and the capabilities of the contract research organization (CRO) of your choice, we’ll identify key issues, then tailor a contracting strategy that:

Protects control of intellectual property
Preserves access to data
Ensures regulatory compliance
Fairly allocates risk

Industry Knowledge

We are advisors who understand the unique challenges drug development companies face, and specifically the need to balance speed with attention to the details that could derail your project.

The Crowell Life Sciences team develops 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:

Have years of in-house and other experience at pharmaceutical and medical device companies
Work with each client on an ongoing basis, thereby enabling the team to provide focused services to meet the specific needs of each client

We have a comprehensive understanding of industry practices, both within geographical regions, and categories of sites—from large academic institutions to smaller private clinics.

We take into account the indication under investigation, targeted patient population, sites and country mix, and our client’s needs and expectations in order to:

Develop contracting models and document templates tailored for the particular participants, study, and country mix
Help our client structure its relationships with vendors, consultants, and contractors so as to manage risk and build in counterparty accountability mechanisms
Bring in, when needed, the experience of local legal counsel with whom we have existing relationships due to previous collaborations in the countries involved in the study

We are better able to negotiate on behalf of our clients by utilizing:

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

A focus on what matters

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.

Our approach, which is modeled on the practices of major pharmaceutical companies, is unique among law firms.

If you are conducting your clinical trials 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. 

A deeper understanding

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.