FIRST IN HUMAN FEATURED ARTICLES

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.

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FIRST IN HUMAN WHITE PAPERS & CASE STUDIES

  • 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 INC Research/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    According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such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.

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FIRST IN HUMAN SERVICES & PRODUCTS

Phase I-IIA Clinical Trials

INC Research/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.

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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.
Cardiac Safety
Cardiac safety concerns can derail your promising product. Failure to evaluate and plan appropriately can leave signals undetected until later, larger studies — a costly scenario. And now regulators expect earlier, more accurate data.
Clinic Profiles
You want to provide a safe environment and a rewarding experience for healthy volunteers during clinical trials. Quintiles delivers that atmosphere, drawing on more than 25 years' experience handling Phase I clinical research and clinical trial monitoring.
Clinical Pharmacology
Clinical Pharmacology — Scientific Steps in Safety, To move from Phase I to Phase IIa and then to guide the dosing-regimen design for Phase III studies.
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