Clinical Research Services

 
 
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Clinical Research Services

Conducting efficient, innovative clinical research from initial planning to closeout

Leidos provides a broad range of clinical services and solutions to researchers, product sponsors, U.S. government agencies, and other biomedical enterprises, hospitals, and health systems.

Our broad research experience enables us to support programs throughout the development life cycle: from concept through the exploratory, development, pre-clinical, and clinical phases, as well as with product manufacturing and launching. Leidos designs and develops customized solutions that support groundbreaking medical research, optimize business operations, and expedite the discovery of safe and effective medical products. We apply our technical knowledge and experience in selecting institutions, clinical research organizations, and independent research facilities to meet the specific needs of each clinical study. We also manage team integration, communication, and contracts throughout the project.

Leidos capabilities include:

Planning Startup Initiation Conduct Closeout
Regulatory submissions Clinical site assessment GCP, GDMP, GCLP training Project management Site closeout
Statistical analysis planning IT infrastructure setup Site initiation Site management Project closeout
Study document development: protocol, manual of procedures, informed consent, etc. Trial master file setup Clinical team integration Subject recruitment plan development Database lock/transfer
Outsourcing coordination Case report form development Clinical trial supplies and logistics Investigational New Drug maintenance Clinical study report
Safety planning Data management plan   Clinical quality assurance  
Study design Laboratory quality management plan   Site monitoring  
QC method/ formulation development, clinical- grade manufacturing, labeling Clinical site budgets and agreement   Scientific meeting planning  
  Data Safety and Monitoring Board creation/management   Biospecimen management  
      Auditing  
      Safety monitoring/reporting  
      Data management  

Finally, Leidos has a proven track record of ensuring that research involving human subjects is conducted in compliance with U.S. and international regulations and guidelines, and we bring this important skillset to the table when developing and implementing clinical approaches for our clients.

Contact Us

For more information about our business solutions and capabilities, contact us today.


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