We Execute Clinical Research and Development Programs with Greater Visibility
Clinipace Worldwide is a global full-service CRO that leverages clinical and scientific expertise with innovative technology to optimize timeline performance, contain costs, and ensure your success
Consider Us Your Clinical Research Sherpas
You depend on a partner who has the global contract research experience to optimize and execute your drug development program.
We’ve climbed the Everest of clinical trials before and we’re ready to do it for you. We’ve completed more than 1,500 clinical trials and 1,500 regulatory and statistical consulting projects with our global services infrastructure. Let us show you how our experience and knowledge can make your trial successful.
Clinical Development
From managing your entire drug development program to conducting an individual clinical trial, our experts bring extensive therapeutic experience in building a well-defined strategy and clinical plan to maximize the success of your drug candidate; and our teams can help operationalize (affordably) your protocol and provide much needed visibility into your studies.
Read More>>
RSD Global Consulting
Whatever the scale or complexity, we have the expertise to move your products from the lab to market while maximizing your success with regulatory authorities. Our consultants collaborate with your experts to construct a strategic plan along with a budgetary analysis so your program stays on track and your stakeholders are well-informed.
Read More >>
Whether you need the full suite of CRO services or a single service, we’re ready when you are
Clinical Development:
|
|
Clinical Development:
- Biostatistics
- Customized sourcing
- Global study feasibility
- Patient recruitment
- Post-approval and registry
- Regulatory submissions and filings
- SAS
- Project management
- Clinical monitoring
- Site selection and management
- Data management
- Medical affairs and writing
- Pharmacovigilance and safety
- Statistical programming
- TEMPO™ eClinical platform
Regulatory and Strategic Development Consulting:
|
|
Regulatory and Strategic Development Consulting:
- Overall regulatory strategy
- NDA, BLA, ANDA, 505b(2), MAA, DMF writing
- Project management
- INDs, Clinical Trial Applications, and IMPDs
- CMC development strategy
- CMO management
- Supply chain management
- Special regulatory designations
- Statistics consulting
- Agency interactions
- Medical writing
- Regulatory writing
- Portfolio development and evaluation
- Product and regulatory intelligence
- GMP, GLP auditing and remediation