Your Clinical Trial is Like Climbing a Mountain

Let our clinical experts do the heavy-lifting and guide you to the summit.

We Execute Clinical Research and Development Programs with Greater Visibility

Clinipace Worldwide is a global full-service contract research organization (CRO) that leverages clinical expertise with proprietary 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.

Learn How We Do It

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.
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RSD Global Consulting

Whatever the scale or complexity, we have the strategic and operational Regulatory, Quality, CMC, Medical Writing and Biostats expertise to move your products from bench to bedside.  More than just your consultants, as your drug development partner we serve as stewards of your therapeutic program helping to manage costs, quality, and deliverables. Our experts apply pragmatic approaches to solving the complex challenges of drug development while our routine interactions with regulatory authorities help ensure their success.

Our Focus is Your Timeline

Milestones like IND filing, start-up activities, first patient in, interim analyses, last patient in, database lock, and clinical study reports are critical timeline events. We have the operational expertise and the technology-amplified service delivery model (dCRO) to keep these milestones on schedule.

Whether you need the full suite of CRO services or a single service, we’re ready when you are

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 & Strategic Development Global 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