Clinical Reach Drug Development b.v.

Company Profile

Clinical Reach is an independent company that aims to be a partner in your development team, from the strategic level down to the level of hands-on support in the execution of individual studies.

Company Profile

We join you in your goal to develop a product that meets regulatory expectations and that will be commercially successful. Pending your needs, we support you in your efforts to:

• Define the target product profile. 
•  Define the development plan that brings you to that target. 
•  Seek key opinion leader and regulatory authority challenge of the target product profile and development plan. 
•  Design the individual studies in your development plan. 
•  Identify the appropriate contract research organization to execute your studies, and work with this external partner on a day-to-day basis until the study has been reported. 
•  Present your plans and data to external parties, including investors, potential licensing partners and regulatory agencies.

Alliances

We are informally associated with various expert companies and individual experts providing services complementary to those of Clinical Reach, including:

• Regulatory services. 
•  Pharmaceutical development and clinical trial material production, packaging and labeling.
• Clinical study execution and management services. 
•  Recording and reporting of electronic patient-reported outcome (ePRO) data. 
•  Bioanalytical services, including biomarker assays and immunogenicity assessments. 
•  Pharmacokinetic and –dynamic data analysis. 
•  Modeling and simulation from clinical trial design to kinetic and dynamic data. 
•  Data management and statistics. 
•  Medical writing.

Keywords

• Target product profile
• drug development
• regulatory challenge
• key opinion leader challenge
• study design and execution