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Advancing Clinical Research
Harvard Clinical Research Institute

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HCRI: a respected leader in clinical research
Harvard Clinical Research Institute provides a full-range of clinical research services for pharmaceutical and medical device developers. As a not-for-profit organization affiliated with the Harvard Medical School, one the world's most respected and renowned teaching institutions, HCRI has access to many of healthcare's most prominent and emerging thought leaders. Among the services HCRI provides research sponsors are:

• Trial strategy development and counseling
• Innovative clinical trial design
• Comprehensive project management
• Highly reliable data management
• Sophisticated data analysis
• Independent clinical reviews of adverse events

Sponsors benefit from HCRI's excellent record, both in the healthcare industry and with the FDA, for more than a decade. HCRI has earned an outstanding reputation for the highest integrity, sound fiscal management, and uncommon responsiveness to sponsors' needs. Results of studies designed and managed by HCRI have appeared in nearly a hundred peer-reviewed publications.

The advantages HCRI offers extend well beyond research services. As a not-for-profit entity, surplus revenues are reinvested in the organization itself. This helps continually improve its research capabilities, knowledge base, and service offerings. And, as an academic research center, its extensive databases are accessible to external researchers to help advance medical science worldwide.

Setting the destination
Finding the optimal strategy

Years of success in trial design
Researchers at Harvard Clinical Research Institute have extensive experience in designing trials that answer critical clinical and regulatory questions. For example, what indication should be pursued? What endpoints are appropriate for the respective study? Does the study target the right population? Will the FDA approve the study design?

Since its inception more than a decade ago, HCRI has designed and implemented more than 100 clinical trials on behalf of sponsors: All have been accepted. In fact, many of the methods HCRI created to evaluate new medical technologies have become industry and governmental standards - clear testimony to the Institute's innovative skills. And, HCRI's biostatisticians are adept in designing trials that capitalize on the most advanced analytical methods. Many of these methods have saved sponsors substantially in terms of human resource and financial investment costs.

HCRI's clinical experts can also provide sponsors access to some of medicine's preeminent healthcare facilities - Harvard-affiliated institutions well-accustomed to the rigors of conducting drug and device trials and the meticulous data gathering processes they demand.

Effective, efficient, and innovative
HCRI understands the critical role trial design plays in determining the success of new therapies. Sponsors must routinely cope with a variety of pressures from investors, competitors, and regulators, often in remote areas of the globe. HCRI sponsors can be assured, however, that the Institute's dedicated trial design team is highly skilled in developing research that generates the required data in the most efficient and effective way possible. They're adept at collaborating with investigators and academic thought leaders throughout all phases of the research process.

Designing trials that withstand the pressures of environmental change is another critical area where HCRI trialists routinely excel. Experience and foresight enable them to craft studies that anticipate an exceptionally broad range of events. And, the contributions of industry and academic thought leaders to the process help ensure success.

Innovative design, research time, and cost control are vital concerns of every trial sponsor, and the rigor of the study itself is critical. Trials designed by HCRI routinely withstand intensive scrutiny, including FDA audits and peer reviews. Defining the right objectives and creating the right design at the outset are essential in HCRI's approach to helping sponsors arrive at their respective destinations.