first-in-human-995x60.png first-in-human-995x60.png

FEATURED ARTICLES

The State Of Clinical Trials In Russia
The State Of Clinical Trials In Russia

Every quarter, Synergy Research Group, a full-service CRO headquartered in Moscow, Russia, issues its Orange Paper. The report, which looks at the state of clinical trials in Russia, is comprised of research done by combing through data from the country’s Ministry of Health. The Orange Paper offers a concise snapshot of clinical trials in the region.

The Q2, 2014 Synergy Orange Paper was just released.  One of the more significant findings is that the gap between previous years’ trials and the current period is closing. In the first quarter of 2014, there were 18 percent fewer trials than in the same quarter in 2013. In the second quarter, there was a gap of only three percent.

  • The Evolving Role Of Pharmacovigilance

    New global regulations have forced the concept of pharmacovigilance to expand beyond just identifying adverse events. Today pharmacovigilance is on the minds of every pharma and bio executive, and it starts earlier in the drug development process. By Dan Schell, Life Science Leader magazine

More Featured Articles

WHITE PAPERS AND CASE STUDIES

  • Patient Access And Patient Care Facilities Expertise

    The Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center (CRC) is located on the fifth floor of the Indiana University Hospital. The close partnership and consistent processes between the Indiana CTSI CRC and our Evansville clinic, along with our expertise in first-in-human studies, makes these combined sites a natural choice for first-in-human studies that combine healthy volunteers and patients. Together, we offer a powerful combination of expertise in patient access and specialist patient care facilities.

  • Clinical Research Unit: Covance & Royal Liverpool University

    The close partnership between the Royal Liverpool University Hospital Clinical Research Unity (CRU) and Covance’s Leeds clinical and expertise in first-in-human studies create a powerful combination of expertise in patient access and specialist patient care facilities.

  • Considerations When Selecting A CRO For Phase I Clinical Studies

    Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

  • Phase I-IIA Clinical Trials Brochure

    At inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.

  • Recruiting Patients With Impaired Renal Function Case Study

    According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.

  • ICON Clinical Development Overview

    ICON is one of the world’s largest providers of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.

More White Papers & Case Studies

SERVICES AND PRODUCTS

Phase I-IIA Clinical Trials Phase I-IIA Clinical Trials

inVentiv Health conducts Phase I-IIa clinical trials quickly and efficiently at its dedicated 22,000 square foot clinical facility comprising more than 200 beds in four independent units. An extensive database and relationships with leading hospitals ensures rapid recruitment of study participants for a wide variety of trials.

Clinical Pharmacology Clinical Pharmacology

The clinical pharmacology team at ICON Development Solutions (ICON) has extensive experience in the design, study conduct and interpretation of clinical pharmacology studies across all major therapeutic areas.

First In Human Clinical Trials First In Human Clinical Trials
Timely and accurate data regarding the safety and efficacy of drug is critical for success at every stage of drug discovery and development.
Early Phase
With a full scope of services from First in Human through Proof of Concept, PAREXEL's early phase operational teams are right where you need us.
Clinical Services Clinical Services

In today’s pressure-filled biopharmaceutical development environment, no company can afford to spend the $800M or more it takes to bring a product from the lab to the marketplace, only to have it fail in critical Phase III clinical trials.

Early Phase Early Phase

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.

More Services & Products

NEWS

More News