Quick study set-up activities

ClinMed is proud to be expert at study set-up with a proven record of speed and efficiency with site selection and coordinating Investigator study teams to maximum efficiency through our clinical support network that consists of some of most respected investigators and key opinion

Feasibility is carried out by our experienced staff basing on the database of reliable investigators. An extensive feasibility assessment is the first step to efficient study conduct with realistic timelines and cost estimates.

ClinMed Pharma is experienced in site contract negotiation as well as submission of Clinical Trial Application to Regulatory Authority and Ethics Committee.

Moving to the next step of the project, our CRAs perform all activities necessary for ongoing monitoring of the study with great focus on quality. As far as audit preparation is concerned, our staff has the medical, technical and regulatory expertise to ensure that standards, processes and personnel are in place to achieve the highest quality. We also deliver training increasing the quality pivotal for the conduct of clinical studies.

ClinMed providesĀ following services:

Study set up
  • Feasibility activities according to the Sponsor’s requirements based on the company’s expe rience and contacts with PIs and sites from the different therapeutic indications
  • Contract negotiation with study sites, investigators and  contracted vendors
  • Preparation of essential documents (e.g. Patient Information Sheet and Informed Consent -Form, Patient’s Diary, Emergency Card, IMP label)
  • Preparation of Clinical Trial Application and submission to the Regulatory Authorities and to Ethics Committees
  • Pre-study visit
  • Medical Writing (Protocol, CRF, IB, IMPD)
  • Preparation of the Investigator files and Central Study File
  • Organization of the Investigators MeetingĀ leaders who specialise in their own therapy areas.
Study conduct
  • Preparation of the Investigator files and Central Study File
  • Organization of the Investigators Meeting
  • Conduct of the study
  • Initiation, monitoring and close-out visits
  • Accompanied quality assurance visits
  • Booster visits to motivate site staff and reach the demanded recruitment rate
  • Preparation of sites for audits and post audit activities: corrective and preventive action plans and their implementation
  • Payments to the hospitals and study teams according to the Sponsor’s requirements
  • Statistical analysis
  • Statistical analysis, Clinical Report, Publications

Clinical professionals outsourcing
Trainings e.g. ICH-GCP for Investigators, ICH-GCP for CRAs