Potential Investigators

ClinicalResearchDev-PDF-ThumbClinical Research Site Development

Collaboration with Allied Clinical Research can provide potential Principal Investigators with:

  • Development of your clinical research capabilities to supplement your Medical Practice with additional income without incurring costs of certified clinical research staff.
  • Allied business development provides investigators with recruitment and contracting services with Pharmaceutical and Device Companies.
  • Highly trained, skilled, and certified Clinical Research Coordinator(s) to your emerging clinical research site.
  • Study accounting records including accounts receivable and accounts payable.
  • Submission to the required Institutional Review Board or Independent Ethics Committee (IRB/IEC) for approval and provide expertise for ongoing regulatory processes.
  • Disease specific counseling and instruction on study medication dosing for each individual patient.
  • A multitude of techniques to assist with patient recruitment including the use of local and centralized vendors to maximize enrollment.
  • Patient follow-up during and immediately after the clinical trial.
  • Developing Informed consent form (ICF) translation into vernacular languages, and assist with the documentation of the informed consent process as required by ICH/GCP/CFR standards and regulations.
  • Completion of all site initiation procedures and trial close-out operations.
  • A proper pharmacy with secured, temperature controlled, and documented storage of investigations medications and background therapies.
  • Archival of trial-related documents and appropriate maintenance for the timeframes specified by the Sponsor.
  • Reporting adverse events, serious adverse events, adverse drug reactions, or device failures to the Sponsor or CRO and the IRB/IEC.
  • Ensuring strict protocol compliance and deviation reporting.
  • Advising & alerting investigators of potential protocol violations.
  • Advising & alerting investigators of potential ICH-GCP violations.