Central Lab Services

FULL-SERVICES OFFER


Medicover Integrated Clinical Services (MICS) provides comprehensive services to coordinate every aspect of clinical trial laboratory part. We combine our professional experience and operational excellence to support clinical trial sponsors and CROs from study setup to final laboratory results submission. Our service portfolio covers laboratory testing, central lab project management, investigator support, sample management, logistics, data management and reporting.

MICS benefit from 96 clinical laboratories within Medicover, regional hubs in 11 countries to support our clients with samples management, logistics and laboratory testing with board range of analytical capabilities, with over 3,000 validated assays in allergy and autoimmune diagnostics, biochemistry & immunochemistry, blood group diagnostics/transfusion medicine, haematology, histopathology & cytology, molecular biology, genetics (including metagenomics), biomarker discovery, tumor markers, microbiome analysis, microbiology & parasitology, advanced immunology, infectious diseases, PK & PD, pharmacology/toxicology. We leverage our geographical and analytical potential, so our clients can benefit from harmonised quality assurance, IT, analytical (equipment, reagents, reference ranges), lab supplies, site support and logistic operations.

We know that modern clinical trials are more and more patient and data centric. Due to this fact we implement Medicover’s motto “Caring For Your Health is All We Do” into our daily practice by understanding the uniqueness of each trial, patient and sponsor’s needs, as a result of our tailored services, sponsor are provided with data enabling significant progress in medicine.

DECENTRALIZED MODEL


Medicover Integrated Clinical Services, as a reaction to today’s clinical trial environment, has successfully created the largest network of central laboratories in Europe and offers centralised regional laboratory services to clinical trial sponsors, also known as DECENTRALIZED MODEL. This new approach is very time and cost effective solution.

In our Decentralized Model, laboratory part of a multinational clinical study, is managed and executed in our locally-based central laboratories, selected by taking into consideration the study sites location, sample stability, transport requirements and national regulations. All logistical and diagnostic procedures are performed in exactly the same way across the facilities and the clinical trial laboratory data are automatically transferred from all lab locations to a single study-specific database, designed and validated to provide access to standardized and consistent data at the end of the study.

 

THE BENEFITS


  • SIGNIFICANT LOGISTICS COSTS REDUCTION of clinical study lab supplies and samples due to decreased number of inter country shipments. Especially when we take into consideration dry ice shipments, we are talking about saving at a level of 30% to 50%. And with today’s market trend of increasing complexity of clinical trials, means more specialised test are required to be performed during the study, frozen shipment are becoming more and more common.
  • FASTER ACCESS TO LABORATORY RESULTS due to shorter turnaround time (TAT). The study specimen is sent ot locally-based central lab for the analysis, and not to a global central lab located even several thousand kilometres away from the site. For special request we can organize access to results after 24h, from the sample collection, but it depends on sites location and the type of test.
  • HARMONIZED CLINICAL LABORATORY DATA from all lab facilities, that have been involved, are provided at the end of a clinical study in one-single and standardized database in a format requested by a Client. The clinical trial lab results are automatically sent from each location during the trial to a study-specific “global” validated database. So, the final product is the same as it is in case of a “regular” (one location) central laboratory but the study cost-savings are undeniable.
  • REAL-LOCAL SUPPORT for investigator site personnel and regionally-located sponsor’s study team thanks to our locally-based staff which support them talking the same language, understanding the culture and providing expertise with regards to national laws, regulations and requirements. So, we save very precious time in clinical trials, needed to e.g. interpret lab results correctly; solve daily study-related queries or kits and study materials re-supply.
  • ACCESS TO LARGE PATIENTS POPULATION of Central and Eastern Europe that are still not utilised to their full potential. These countries, like Russia, Georgia, Moldova, Serbia, Bulgaria and Turkey provide access to drug naïve patients, centralised healthcare systems, well-educated and motivated investigators and overall competitive study logistics costs.

GLOBAL CAPABILITIES


Global Capabilities

CLINICAL TRIALS SERVICES


MICS offers a comprehensive clinical trial central laboratory services to the pharmaceutical and biotechnology industry.

We coordinate every aspect of a clinical trial laboratory part, starting from study set-up and laboratory supplies through investigator site training and logistics planning to resolution of data queries and final data submission.

Clinical Trial Services

These activities are coordinated and reported through Lead Project Manager. Our experience project manager are available to the clients and investigators throughout the whole course of the study. They are able to efficiently coordinate all laboratory related activities:

  • Training of investigators and their staff
  • Shipping of standardized lab material to all centres
  • Coordination of specimen transportation
  • Searching for missing data
  • Generation of clean and reliable database

Our project management team ensures that your clinical trials runs smoothly, effectively and cost-efficiently. They are very experiences in meeting project timelines and budgets.

 

COLLECTION LAB KITS


We designed easy -to-use samples collection kits to reduce the risk or pre-analytical errors and maintain the sample integrity during transport:

  • Custom-built to meet protocol and visit requirements
  • Pre-formatted AWBs to minimize paperwork at the collection site
  • Customized laboratory requisition forms
  • Pre-labeled collection tubes, to minimize errors
  • Specimen collection/handling instructions provided in an instruction brochure

Laboratory Kits Monitoring:

  • Expiration date
  • Study sites stock status
  • Collection kits and laboratory supplies re-supply

lab kits

ONLINE REPORTING


LabOne

MICS offers online access to lab results through proprietary software called LABONE:

  • 21CRF part11 compliance
  • Web-based and secured
  • Real-time with 24/7 access
  • Colour-coded results
  • Reporting modules:
    • Cumulative or Incremental
    • Abnormal
    • Trends
    • Custom

 

 

 

DATA MANAGEMENT


Our Data Management team is committed to delivering clean data, on time and in the format requested by the client.

Data Management and reporting

BIOREPOSITORY


Biorepository

We offer secure frozen (-20C, -80C and liquid nitrogen) specimen storage to support your clinical trial samples. Tracking and bar-coding systems are used to maintain an accurate record of your samples and allow us to quickly access samples. Every moment of sample is tracked and is auditable.

We have backup generators to protect the integrity of your study specimens in case of power outrages.

We have also implemented procedures for identifying discrepancies at the time of receipt, so specimen will not be stored with incorrect information.

CONTACT US


Where to find us 

163 Marynarki Polskiej Str.
80-868 Gdansk, Poland

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Mo-Fr, between 09:00-17:00 CET
+48 602 443 552

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