Conducting clinical trials

At ClinMed, we conduct comprehensive clinical trials and prepare all necessary documentation. We often start cooperation at the stage of the authorization to conduct a clinical trial. We are a member of the association, which means that we honestly follow all the rules of conducting clinical trials and ethical principles adopted by the association.

During the research we focus primarily on obtaining the most accurate results while maintaining the safety and well-being of the patient.

Quick study start-up

We are experts at Site 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 leaders who specialise in their own therapy areas.

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 offers following services

  • Medical Writing (Protocol, CRF, IB, IMPD)
  • 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
  • Preparation of the Investigator files and Central Study File
  • Organization of the Investigators Meeting
  • Preparation of the Investigator files and Central Study File
  • Organization of the Investigators Meeting
  • Conduct of the study
  • Initiation, monitoring and close-out visits
  • Booster visits to motivate site staff and reach the demanded recruitment rate
  • Accompanied quality assurance visits
  • 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