ATMP | Investigational Medicinal Product | Medical Devices | Imaging trials | Non-Interventional Studies

ClinMed offers the following services:

EU LEGAL REPRESENTATION

Clinical research - CRO services Poland, Europe, USA

Having 13 years’ experience with investigational medicinal products and medical devices studies we have developed know-how to be very efficient in conducted projects. ClinMed’s extensive understanding of the IMP and medical device regulatory issues enables our clients to save time and money with their studies. Our medical device experts have U.S. FDA as well as European regulatory experience and are flexible to address wide variety client’s demands.

Study set up
  • 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
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
  • 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

Latest News

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Clostridium difficile study, 23 sites in Poland
11 Jan, 2016

ClinMed has accomplished the start-up phase and begins initiation of 23…

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Pancreatitis in Cystic Fibrosis patients
16 Aug, 2015

ClinMed begins phase II study in Patients with Cystic Fibrosis…

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Full service Anal Fissure trial
23 Jun, 2015

ClinMed has been selected as full service provider in phase…

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ClinMed at Munich conference
3 Mar, 2015

ClinMed present at the Clinical Trial Innovation Program in Munich,…

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