Calibration Services for Contract Research Organizations

Contract Research Organizations (CROs) support research and development efforts across various industries, including pharmaceuticals, biotechnology, and medical devices. While there are overlaps in the services provided by CROs across these industries, there are also specific differences influenced by each sector's unique characteristics and regulatory environments. Instrument calibration is a common requirement to ensure the reliability and validity of research data. Transcat has the experience to help CRO labs comply with regulations through validation and compliance services tailored to their types of test instruments and lab environments.

Pre-clinical and clinical trials involve a series of well-defined procedures to ensure compliance with applicable regulations such as Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and other relevant regulatory standards. Transcat offers instrument validation and compliance services to support these requirements for many clinical trial testing procedures including: 

• Sample Collection 
  Collecting clean samples is crucial in clinical trial testing to ensure the accuracy and reliability of the results. Sterile swabs, pipettes, spatulas, containers, and other tools are used to collect samples aseptically, especially in biotechnology testing where contamination risks are high. Transcat equipment validation services cover autoclaves, sterilizers, and depyrogenation ovens for effective sterilization within test lab operations.  
• Sample Preparation  
  Using calibrated instruments and following sample preparation protocols ensures the test results' quality, integrity, and reproducibility. Transcat Pharmaceutical, Medical Device, and Laboratory Validation Services cover common instruments used for the preparation of clinical trial samples, including centrifuges, homogenizers, sonicators, pipettes, ovens, vacuum concentrators, lyophilization (freeze-drying), and rotary evaporation equipment.  
• Analysis 
  Instruments used to analyze prepared samples require calibration to ensure proper functioning and accurate results. These include chromatography systems (HPLC, GC), spectrophotometers, dissolution testers, microscopes, pipettes, pH meters, and moisture analyzers.
• Temperature Control 
  Test samples often require storage within temperature-controlled environments from simulating extreme temperatures to growing cultures. Transcat Equipment Validation Services verifies that laboratory equipment performs to the manufacturer’s specifications. This includes specialized services for incubators, stability chambers, freezers, refrigerators, and cold rooms.  
• Environmental Monitoring  
  Instruments used for environmental monitoring within test lab facilities, such as temperature and humidity loggers, particle counters, and air samplers, require calibration for accuracy and compliance.  
• Quality Assurance and Compliance 
  CRO laboratories must maintain quality assurance procedures to ensure compliance with Good Clinical Practice (GCP) guidelines and Good Manufacturing Practices (GMP) regulatory requirements. This includes conducting proficiency testing, participating in external quality assessment programs, performing regular audits, and maintaining equipment and test and measurement instruments. NEXA | EAM, a Transcat Company, provides quality management services to ease the compliance burden for CRO laboratory equipment and facilities. 

Pharmaceutical, Medical Device, and Laboratory Validation Services 
These specialized validation services provide documented evidence that your systems, facilities, and processes perform their intended functions according to specifications set by the FDA or custom protocols. Service options through NEXA | EAM, a Transcat Company, include qualification of new installations, validation, revalidation, and instrument calibration. 

Instrument Metrology and Repair Services 
Transcat Biomedical is a leading, national provider of quality instrument metrology and repair services. Our services are available on-site or from one of our ISO 17025-accredited biomedical labs. 

Pipette Calibration and Supplies 
Transcat Pipettes offers 3–5-day turnaround for pipette calibration services and as fast as 24-hour turnaround within defined service areas. We are also a multi-brand distributor of high-quality pipettes, pipette tips, and benchtop equipment.  

Enterprise Asset Management (EAM)
NEXA | EAM, a Transcat Company, provides technical, consulting, and staffing solutions to improve asset management programs for life science industries in North America, Europe, and Asia Pacific. EAM services include calibration, maintenance and spares, reliability, CMMS, quality, compliance, and commissioning, qualification, and validation services. 

For more information about our accredited calibration and validation services for CRO applications, call one of our calibration professionals at 800-828-1470 or contact us.