Clinical Services

What are the Clinical Stages? Early Stage Studies: Phase I/IIa

Well-designed Phase I/IIa trials provide the robust data you need to avoid unnecessary developmental delays, reduce your risk of costly later-stage trial failures, and support earlier, better-informed “go/no-go” decisions.

We offer fully integrated Phase I through Phase IIa development programs across a wide spectrum of therapeutic areas,

PRU also provides dedicated support for Proof of Concept studies, which are designed to demonstrate early signals of product’s efficacy in the targeted patient population.  We integrate our expertise in drug development, regulatory strategies, and clinical pharmacology so you can make better and faster decisions about which products have the best potential for success – reducing your chances of costly late-stage clinical development failures.

Pivotal Clinical Trials: Phase IIB/III

Many biopharmaceutical companies are exploring new types of strategic partnerships to help them save time and money during the most challenging and costly stage of product development – pivotal Phase IIb/III clinical trials.  By working with the right strategic partner for these vital studies, biopharmaceutical companies can greatly increase efficiency by focusing their internal resources on the highest priorities – such as discovery research and product marketing – while relying on their partners for a broad array of specialized knowledge and infrastructure, such as in-depth therapeutic-area expertise, clinical trial experience, global patient and investigator resources, and regulatory knowledge.

Whatever the size of your study, we can plan and manage your pivotal trials from beginning to end, including: study design, protocol development, site and patient recruitment, clinical monitoring, database design, document management, clinical logistics, and medical writing. PRU works closely with investigators, patients, and sites to ensure that all protocols are followed and all deadlines are met – reducing the costs, risks, and delays of conducting your trials.

Peri-approval/post-marketing studies: phase IIIb/IV

We have enhanced our services in number of vital areas to improve our support of global Phase IIb/III trials, including:

  • Study start-up and patient recruitment
  • eClinical technologies and data management
  • Therapeutic area expertise
  • Site management
  • Medical writing
  • Clinical logistics services