Solutions for the Pharmaceutical and Biotech Industry

Project Management

We combine experience, scientific knowledge, and operational expertise with responsibility and integrity to create a powerful value proposition for pharma and biotech companies. Our experienced Project Managers coordinate all activities related to the study, manage study timelines and budget, and maintain close communication with the sponsor, project team, and sites.

Orphan Drug Designation

Orphan drugs are medicinal products intended to diagnose, prevent or treat rare diseases, which are diseases affecting less than 1 in 2,000 persons or a maximum of 250,000 citizens in the European Union.

The Orphan Drug Designation is a legal process that enables the designation of a medicinal substance with therapeutic potential for a rare disease, either prior to its initial use in humans or during its clinical development.

We specialize in handling the submission to the European Medicines Agency (EMA) and manage all subsequent procedures involved. We will assist you in evaluating the application based on the necessary criteria to obtain a positive opinion from EMA and the Committee for Orphan Medicinal Products (COMP).

Medical Writing

We offer comprehensive, reliable medical writing support to expedite submissions and approvals. Our medical writing services are offered as an integrated part of our clinical development expertise and include Protocol development, ICF, Investigator Brochure, Clinical Study Report Writing, Regulatory Writing, Safety Documents.

Monitoring

We provide on-site monitoring, site management and administration services in Poland. Routine monitoring is performed accordingly to ICH GCP rules, FDA guidelines and local regulatory requirements.

Data Management

We offer a full spectrum of data management services including eCRF design, set-up, and maintenance.

Pharmacovigilance

Through collaboration with vendors, we provide a range of Pharmacovigilance services, which encompass the development of a safety management plan, conducting safety reviews, and submitting safety reports to the relevant regulatory authorities in accordance with GVP.

Non-commercial clinical trials

We help in the organization and conduct of non-commercial clinical research (academic trials).

Pre-clinical trials

We have experience in designing and conducting preclinical studies in collaboration with specialized sites.

Training

Our offering encompasses comprehensive GCP training designed for Investigators and Study Teams, equipping them with a thorough understanding of the clinical trials and GCP principles, and the processes associated with the study.

Site management and logistic

Managing clinical and medical supplies is critical in ensuring the successful completion of Clinical Trials.

CRSN – Clinical Research Sites Network

We have high expectations that our partnership will introduce fresh prospects for the advancement of healthcare. Our expertise lies in the coordination of clinical trials at the site level, granting our partners access to an extensive network of sites. We provide convenient solutions that enhance the efficiency of clinical trial management through a unified and simplified approach.

Clinical Trial Insurance

We arrange Clinical Trial Insurance policies in cooperation with global insurance providers including Allianz, HDI, Generali, etc.