Clinical Trials

How can we help?

We provide comprehensive support for clinical trials, from the regulatory part and study start to submissions, project and site management, and medical writing services to laboratory services.

We can offer collaboration with our partners that can make our list of services complete if a clinical trial is initiated for an innovative drug (IND) or generic produced by a pharma or biotech company.

Our clients are usually small or mid-size pharma companies, start-ups, or global Clinical Research Organisations (CROs) who need extensive help in recruitment, study performance, or product penetration in the market of Southeast Europe and the Balkan region.

Our Key Opinion Leader (KOL) network and vast experience in clinical trials can offer you coverage of different therapeutic areas. As a company with an extensive QA background, we provide all our services at a top-quality level, and it is our responsibility to ensure that all vendors and sites included in the study will do the same.

Our lab partner:

Where we operate

The company is based in Zagreb, Croatia, which has been a member of the EU since 2013. We have a very favorable strategic position as the youngest EU member, making us still financially attractive and profitable compared to other members. Additionally, we are historically and geographically linked to the Balkan region, so we have our KOLs there as well as logistics.

Moreover, conducting a study in Croatia automatically implies data recognition in almost all Balkan member states (Serbia, Bosnia and Herzegovina, Montenegro, North Macedonia, Kosovo, Albania). We also have good neighborly relations with Slovenia; therefore, the two largest clinical centers in Ljubljana and Celje are our partners in conducting the study.

This covers more than 55 million people of different nationalities and races, thereby increasing the success of the completed study, which prioritizes having diverse and well-analyzed data.

Clinical trial services we can offer

Services we can offer are splitted in two parts, pre-market and post-market servicies.

Pre-market servicies are linked to Clinical Trial and laboratory servicies, and post-market servicies to all activities needed for launch of the product on the specific market. In our RFP we provide a detailed list of all serivices with quotes.

 

Pre-market services

  1. Business strategic Support
  2. Project Management activities
  3. Regulatory submissions support to different authorities on local and regional level (Croatia, Slovenia, Serbia, Bosnia and Herzegovina, Montenegro, North Macedonia, Kosovo, Albania, Turkey, Spain, Kazahstan,  EMA (CTIS), FDA USA, Health Canada)
  4. Site selection and feasibility process support
  5. Site set-up and Study operations support
  6. Medical writing
  7. Study supply management
  8. Data Management (Vendor company)
  9. Pharmacovigilance in clinical trials (Vendor company)
  10. Auditing and pre-inspection visits (certified EMA and FDA USA auditor for GCP, GVP, GMP, GcLP, GDP)
  1. Research and Development (R&D) / Applicative Support
  2. Analysis of Nitrosamines, APIs, Preservatives, contaminants
  3. Method Transfer Services
  4. Compliance with CFR Part 11
  5. Software and hardware development Support
  6. Optimization of Hardware and Software for High-Throughput Analysis

Post-market services

  1. Regulatory CMC submissions support to different authorities on local and regional level (Croatia, Serbia, Slovenia, Bosnia and Herzegovina, Montenegro, North Macedonia, Kosovo, Albania, Turkey, Spain, Kazahstan, EMA, FDA USA, Health Canada)
  2. Registration of product – DCP, MRP, CP (Vendor company)
  3. Marketing and sales
  4. Pharmacovigilance (Vendor company)
  5. Medical writing
  6. Labeling
  7. Import/Export
  8. Drug wholesale
  9. Auditing vendors and MAHs and pre-inspection visits (certified EMA and FDA USA auditor for GCP, GVP, GMP, GcLP, GDP)

Request a Quote

Please fill out the fields below and one of our specialists will contact you shortly.

Email: info@proqlea.com
Josipa Draženovića 2A, 10 000 Zagreb
Croatia
We will get back to you as soon as possible.