FDA assistance

• IND/IDE preparation
• Meeting facilitation and preparation
• NDA/PMA preparation

Project management

• Each project manager (PM) has at least 3 years of experience in project management and 10 years of experience in clinical research

Protocol and informed consent development

• Conduct strategic planning meetings to ensure protocol meets all data needs, safety needs, and regulations
• Design and review of protocols, ICFs, and HIPAA authorizations

Case report form development and guidelines

• QC processes ensures you are getting the data you need in an easy-to-follow format for study coordinators
• Experience with Electronic Data Capture (EDC) and electronic patient diary records

Study-specific SOPs that ensure compliance with all applicable regulations and your own company’s policies and procedures

Site Selection and Qualification

Contract and budget preparation, negotiation, and implementation for study sites and other vendors

Investigator Meeting preparation and execution

Monitoring

• CRAs hold an RN, BS, or MS degree and have at least 3 years of clinical research experience
• We have a low attrition rate of CRAs, thereby increasing the consistency of data capture in your clinical trial
• We offer monitoring in English and Spanish and have partnerships with CRAs who offer monitoring in French and German
• CRAs all have experience in conducting:
  • Pre-study visits
  • Study initiation visits
  • Interim monitoring visits
  • Audit preparation or for-cause monitoring visits
  • Study close out visits

Therapeutic Area Experience that includes:

• Oncology
• Gastroenterology
• Cardiology
• Respiratory/pulmonary
• Rheumatology
• Hematology
• Orphan drugs
• Pediatrics
• Apheresis