Pra Worldwide Development

PRA’s Therapeutic Expertise group is a scientific and medical expertise resource offered by PRA to provide clinical development support. 

Our Therapeutic Expertise service provides: 

• A board of certified physicians and industry experts covering a broad range of therapeutic areas

• PRA and clinical staff with training and support during operational delivery of clinical services 

• Services through all phases of drug development, including and specifically, in clinical medicine, biostatistics and regulatory submission strategy

PRA’s patient recruitment exceeds 350,000 patients from populations targeted to studies in our core therapeutic areas. These include: 

• Cardio-metabolic 

• Infectious diseases 

• CNS and Neurosciences (neurology and psychiatry) 

• Oncology and hematology 

• Internal medicine with a focus on Respiratory/Allergy 

Feasibility Assessment 

PRA’s feasibility assessments provide in-depth analysis of your study to reduce risk and increase the probability of a successful outcome. 

PRA provides: 

• Strong relationships with key opinion leaders around the globe to provide local country knowledge 

• An excellent understanding of local regulatory environments and customs to ensure optimal trial planning and execution 

• The use of sophisticated Medical Informatics data and processes to optimize each protocol 

Whatever the trial requirements, our therapeutic and operational experts will evaluate the critical, indication-specific factors required for success, including: 

• Protocol and study design

• Strategic country and site selection using novel database analytics 

• Efficient global study activation 

• Proactive patient recruitment and retention strategies 

• Integrated project management by an experienced global team 

Additional Services

PRA’s therapeutic experts also perform consulting services, including: 

• Clinical development program and protocol design 

• Integration of scientific/clinical, regulatory and economic development needs 

• Scientific Advisory Board formation and memberships 

• DSMB charters, membership 

• Training for core team members (e.g., CRAs) in:
  
  • Disease background 
  • Current standard of care 
  • Alternative treatment options 
  • Basic diagnostics 
  • Patient safety 
  • Trial specifics to fully meet investigator and client needs