Clinipace offers clinical research services as well as support for regulatory strategy and operationals.

At Clinipace, a global, full-service contract research organization (CRO), our approach to clinical research is personal. With personalized services and solutions, local regulatory expertise and therapeutic leadership, we overcome the most difficult industry challenges across all major therapeutic areas.

Services
Regulatory affairs
Regulatory strategy and execution
Regulatory agency meetings, responses and liaison services
Investigational applications (IND/IMPD/CTA/CTX) and amendments
Marketing applications for drugs and biologics (ANDA/NDA/MAA/505(b)(2)/BLA)
Type II drug master files (DMF)
Orphan indications and fast track designations
CMC strategy, management and communications
Drug development strategic consulting
Process controls, specifications and formulation assistance
CMC project management
Writing Module 3 documents
CMO selection and management
Supply chain coordination
Medical writing of scientific, medical and technical documentation for drugs, devices and biologics
GxP quality assurance
Regulatory operations
Biostatistics and statistical programming
Clinical analytics
Clinical data management
Clinical operations
Clinical technology
Investigator recruitment and site selection
Medical monitoring
Project management
Quality assurance
Safety/pharmacovigilance