Experience

13 years experience in wide veriaty of therapeutic indications in phase I-IV trials, medical devices...

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CRO Poland

The key drivers of the clinical trials in Poland are the population size, efficient patient recruitment and high quality of data...

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ECRF & DM

High quality eCRF, data management and statistics services enable us to deliver data rapidly, with quality assurance at...

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Clinical trial services - Europe - Poland

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

ClinMed offers the following services

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.

Clinical trials on commission - Outsourcing

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

ClinMed opens new office in Central London
ClinMed opens new office in Central London

Clinmed are delighted to inform our clients that we have kicked off the New Year with the opening of our new office in Central London.

ClinMed Pharma CRO became part of Neuca Group
ClinMed Pharma CRO became part of Neuca Group

ClinMed Pharma, CRO with developed know-how in medical devices studies...

Meet ClinMed team at ICI Meeting, Tel-Aviv 2-4 DEC 2018
Meet ClinMed team at ICI Meeting, Tel-Aviv 2-4 DEC 2018

ClinMed will take part in ICI Meeting, medical innovation technology...

Implantable cardioverter-defibrillator
Implantable cardioverter-defibrillator

ClinMed successfully complete study with implantable cardioverter-defibrillator for the top...

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