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Quality, timeliness, accuracy

  James Carlson,
Pharm. D.
  

Quality, timeliness, accuracy are the standards of excellence established under the sound leadership of James Carlson, Pharm. D., founder and President of PRACS Institute, Ltd. With over 25 years of dedication to the practice of research, Dr. Carlson's vision of becoming a premier resource for contract research has become a reality.

PRACS Institute, Ltd., was established in 1983 and began operations in a small facility with only a few staff. In response to a dynamic research environment and our growing client base, PRACS has expanded services by adding staff expertise and relocating to state of the art facilities outfitted with state of the art equipment. PRACS has further addressed industry growth demands by accommodating both in-house and ambulatory clinical studies, expansion of bioanalytical services, establishing in-house clinical laboratory services, broadening our statistical and medical writing services and expanding information technology support services.

As a reflection of our midwestern work ethic, all PRACS departments are eager and willing to tailor their services to meet sponsor needs. In addition, if your individual research project demands exceed the expertise or capabilities of our staff or bioanalytical equipment, we will eagerly identify a qualified provider to ally with PRACS to meet your project needs. Our long-standing working relationship with other industry service providers allows us to offer a seamless project management team. Our goal is to produce quality results in a timely and cost effective manner.

PRACS offers:

  • Two locations with nineteen study units
  • Over 600 in-house beds
  • Experience with Phase I - IV, OTC and cosmetic/personal care research
  • On-site CLIA-certified clinical laboratory
  • On-site bioanalytical laboratory
  • Bioanalytical assay method development, validation, and cross validation
  • Protocol and consent document development
  • Development of data collection and case report forms
  • An independent IRB
  • Electronic submission experience
  • Administrative staff to track study and regulatory documents
  • In-house statisticians
  • Quality assurance staff for Clinical, Bioanalytical, and Statistical oversight
  • Innovative, responsive, flexible Information Technology staff

Research expertise

The dedication and meticulous nature of Dr. Carlson and his research team is reflected in the high volume of repeat business from satisfied clients. The PRACS team offers unique clinical study design, detailed pharmaceutical analysis, and careful study compliance culminating in a submission package meeting or exceeding regulatory requirements.

Our research experience includes:

  • Age/Gender-specific studies
  • Bioavailability
  • Bioequivalence
  • Definitive QTc trials
  • Dermatology, including topicals and transdermal delivery
  • Dose-ranging
  • Drug interactions
  • Efficacy and claims substantiation
  • Pharmacokinetics
  • Pharmacodynamic modeling
  • Proof-of-concept studies
  • Safety and Tolerability
  • Sensitization and Irritation patch studies

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