Clinical Trial Logistics

Transcription

1 Company Brochure Clinical Trial Logistics

2 contents About us Values Facility Quality Management System Services Why PCS Clinical Trial Logistics

3 about us MEET US PHARMA COMPLEX SOLUTIONS LLC is based in Warsaw, which is a modern business center in Central Europe. Warsaw is the scientific, cultural, political and economic center in Europe. The company was founded based on knowledge and experience of four friends associated for years with pharmaceutical industry. We specialize in the logistics of clinical trials offering the highest quality service.

4 values We work with passion and commitment for our client s success

5 facility PCS warehouse is located in Duchnice only 15km from Warsaw city center. Specially equipped warehouse of class A fulfills the requirements of Good Manufacturing Practice. Main advantages of the location: travel time to Warsaw is approximately 25 minutes during peak hours travel time to the airport is approximately 20 minutes during peak hours good connection to capitals of neighbour countries localization on the logistics hub in Eastern Europe

6 quality management system Comprehensive clinical trials logistics service adjusted to customer needs. Quality Management System consistent with the principles of GMP, validation of all processes. Controlled storage conditions Manufacturing processes, packaging, repackaging, labeling in cold chain conditions.

7 quality management system

8 quality management system PCS operates in accordance with the applicable legal guidelines and regulations relating to Quality Management Systems, in particular with the requirements of GMP, GSP, GDP and GCP. Our efforts to continuously improve upon high quality service includes focusing on the risk management processes, as well as key quality management processes such as: effective supervision of withdrawals / holds outstanding annual reviews of the quality of products change management management of deviations corrective / preventive actions (CAPA) qualification of suppliers processes carried out regularly qualifications / validation oversight of the process complaint

9 services transport For Sponsors, CRO s and Research Institutes we offer transportation services of pharmaceutical goods under controlled temperature regime throughout Europe.

10 services transport We use vehicles equipped with modern cooling devices for pharmaceutical cargo transportation under temperature regime 2 C 25 C. Cooling devices are duplicated and works independently. Delivery of frozen shipments of IMPs ( dry ice). All vehicles are also equipped with satellite tracking system (GPS). GPS satellite system enables, tracking shipments in transit, that is, online monitoring of the current location of the goods at any time of the transport process. Safety and quality of transport in all transport processes is enhanced this way, with emphasis on punctuality.

11 services Transport PCS has a highly efficient distribution network within Poland, Baltic and Central European countries. Shipments in this region can be done within maximum 24 hours. Distribution to most other countries of continental Europe is also possible within maximum 48 hours. PCS offers quality and reliable service using the fleet with temperature conditions 2 C 25 C. We also guarantee temperature conditions up to minus 70 C (dry ice) using thermoboxes to transport deep frozen products (e.g. blood). Track and Trace - product traceability from acceptance to delivery.

12 services Scope warehouse services Range of services in Manufacturing Plant is being offered in all temperature zones: ambient, cold and frozen. Storage of: Investigational Medicinal Products Medicinal Products Medical devices Lab kits Bio samples

13 services Scope warehouse services Qualified Person services: batch releasing of investigational medicinal products in accordance with Good Manufacturing Practice Certification IMPs for use in clinical trials in Europe in accordance with the Clinical Trials Directive 2001/20/EC Packaging, repackaging, labeling Preparation of ID number lists for Investigational Medicinal Products Blinding procedure of IMPs Preparation of Technical and Quality Agreements for organizations throughout the Supply Chain Provide Regulatory and Quality strategic guidance and support for EU product registration for medicinal products and diet supplement and medical devices Import medicinal products or intermediate products, for use in clinical trials in order to comply with EU Good Manufacturing Practice Standards.

14 services Scope warehouse services Qualified Person services: Logistics Project Management of clinical trials Conducting of bioequivalence and biosimilar clinical trials Import of investigational medicinal products, lab kits, medical devices, bio samples Preparation and shipping of IMPs, medical devices, lab kits, bio samples and other study materials to sites through EU Export of IMPs, medical devices, lab kits, bio samples and other study materials to non EU countries Bio samples handling, site collection, local depot storage, export Return of IMPs from clinical sites to the depot, incl. storage Recall of IMPs and clinical supplies Destruction of IMPs and other study materials

15 why pcs Over 20 years of experience in pharmaceutical business of it s founders, allows to use of the customer potential, solving at the same time all the emerging issues. Meeting of all customer needs in order to ensure the complete and professional service in accordance with the requirements and expectations. Always ready to implement solutions built to suite if they provide increased efficiency and lower costs for the customer. Wide range of pharmaceutical logistics services in one company. PCS is compliant to international standards and systems: - GMP, GSP, GDP and GCP - SOP governed - Compliance and certification of local requirements We are proud of our services but still constantly improving. Confidentiality at all times. Choosing the right partner for clinical trials logistics is a natural and critical issue when planning growth and development. PCS is your choice.

16 contact Lukasz Nowaczek - Business Development Director T: Mail: lukasz.nowaczek@pcsolutions.pl Pharma Complex Solutions LLC Ożarowska 40/ Duchnice, Poland Clinical Trial Logistics