Clinical Research Services in Poland
We provide a full range of CRO services for both drug and medical device trials, and bring a high level of expertise and valuable technology to each clinical trial that leads to achieving the highest quality results.
We provide accurate clinical trial data within clients' timelines which allows them to make cost-efficient decisions about their product's efficacy, safety, and marketability. We are a partner and contributor, not just a vendor.
Our services include:
Pre-study Activities
- Study development
- Feasibility & Site Selection from our database of experienced high performers
- Contract negotiation with Investigators and Institutions
- Essential Documents preparation and translation including Patient Information, Diary and Informed Consent Form
- Site Evaluation/Qualification Visits
- Study Files Preparation
- Regulatory & EC submission for both drug and medical device trials
Site Initiation
- Investigator Site File and Central File preparation and maintenance
- Site GCP training
- Site ISO 14155 training for medical device trials
- Site Initiation Visits
- IATA compliant study specimen management training
- Patient recruitment services
- Patient follow-up training to increase protocol compliance and limit number of lost to follow-up patients
Clinical Monitoring
Regulatory Services
- CTA submissions to Regulatory Authority & Ethics Committees for both study drug and medical device trials
- Regulatory maintenance including submission of amendments and notifications
- Obtaining import/export approvals for investigational products and medical devices
- EU Legal Representative services
- Registration of medical devices to use on Polish and EU market
Site Management
- Payments to the Institutions, Investigators and Site Teams
- Regular contact with Sites to motivate the site team members, increase patient recruitment rate and limit number of lost-to-follow-up patients
- Distribution of study drug/medical device to the Sites
- Regular ICH-GCP, ISO-14155 and study specific trainings
- Travel cost reimbursement to the patients participating in the trials
Study Close-Out
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Polish CRO for Medical Devices & Medicinal Products
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The material that is contained on this website is provided for general information purposes only and does not constitute professional advice and should not be relied upon. To the extent permitted by law we do not accept liability for loss which may arise from reliance placed on any material contained on this website.