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Precision Research, Inc.

Description: 

OUR NICHE
Medical Writing and Document QC

At Precision Research, Inc. we give your projects our undivided attention. You benefit from our experience in working with clinical documentation, from both a regulatory medical writing and quality control perspective. We resource our responsibilities appropriately to ensure our clients receive the personal service they deserve and expect, with attention to detail on all projects. At Precision Research, Inc. we are committed to providing high quality work within your timeline and budget requirements.

Take advantage of our proven leadership:
Nancy Sobieck, President and Sr. Director, Medical Writing of Precision Research, Inc., with over 28 years of industry experience, 20+ within Regulatory Medical Writing.

Christopher Cusumano, Director of Document Quality Control at Precision Research, Inc., with over 26 years of clinical industry experience, 15+ within Document Quality Control.

Benefit from our full complement of experienced and professional Medical Writers and Document Quality Control experts.

The capability to provide the services you need:
•Medical Writing - virtually any document, including:

  •  Phase I-IV Clinical Study Reports
  •  Clinical Protocols
  •  Investigator Brochures
  •  Briefing Documents
  •  Long-term Safety Updates
  •  Patient Narratives
  •  Clinical Sections of NDAs and BLAs, including
    •  Section 2.5 Clinical Overview
    •  Section 2.7.2 Summary of Clinical Pharmacology
    •  Section 2.7.3 Summary of Clinical Efficacy
    •  Section 2.7.4 Summary of Clinical Safety
    •  Integrated Summary of Safety (ISS)
    •  Integrated Summary of Efficacy (ISE)

Expertise in a wide range of therapeutic areas:

  • Oncology
  • Hematology
  • Anti-infectives
  • Cardiovascular Medicine
  • CNS
  • Pain Management and Anesthesia
  • Women's Health
  • Internal Medicine
  • Immunology
  • Gastroenterology
  • Respiratory Medicine
  • Diagnostic Imaging
  • Drug Delivery (including liposomes)
  • Medical Devices

Document Quality Control-all documents above, including supportive data

 

Services: 

Clinical Study Reports, Expert Reports, Medical Writing, Quality Assurance/Control, Regulatory Document Preparation

Contact Information: 

Precision Research, Inc.
5 Great Valley Parkway, Suite 283
Malvern, PA, 19355, USA
Phone : 6102961747
Fax : 6102961745
Internet : www.precise.net
Email : nsobieck@precise.net
Contact Person : Nancy Sobieck