What We Do
CLH offers comprehensive legal services designed to meet the full spectrum of your contracting and business needs. Our practice encompasses contract drafting, review, and negotiation. We also handle international legal matters, the strategic design of business and legal operations as well as complete contract lifecycle management (CLM) solutions. Whether you require support on a single agreement or a long-term legal partner to strengthen your organization's contracting function, CLH delivers senior-level legal professional services tailored to your objectives.
Services
Clinical
This initial clinical stage is crucial. When you have identified a CRO, our responsibilities begin. In conjunction with the CRO we will work with department leads to create process standardisation and approval points, reducing the risk of missed steps or unnecessary waiting time.
Your company is legally responsible for the proper conduct of your trials, even when delegating duties to a chosen CRO. Failing to meet Good Clinical Practice (GCP) guidelines or FDA regulations can lead to clinical holds, delayed approvals, or complete program derailment. We will help you have the right contract in place in order to minimize the risks.
Some final responsibilities during this phase that we will help you accomplish include budget development and contract negotiation which establish the financial and legal framework under which sites operate and must be completed before activation. Confidentiality agreements, site budgets, and clinical trial agreements. These can each become bottlenecks if ownership and escalation paths are unclear. However with our expertise, they will be avoided.