According to Evaluate Pharma worldwide prescription drug sales will grow at 6.4% CAGR between 2018 and 2024. Oncology is the therapeutic area forecasted to have the fastest growth at ~12% and maintain the largest market share among therapeutic areas.  This growth will be accomplished through the discovery of new molecules and the successful development and execution of clinical trials.    

Central Laboratory Services:  Central laboratory is a key component to clinical trials and is responsible for helping sponsors enable laboratory testing in global clinical trials by providing specimen collection kits, a courier network, a biorepository, plus project management and data management.  Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.  For us, we define Central Laboratory Services to include:
  • Project management
  • Global investigator support services
    • Supply of specimen collection kits and lab manuals
    • Telephone and portal support
    • Lab report delivery
    • Alert delivery
    • Query management
  • Courier services for sending kits to sites and samples to laboratories
  • Lab data management services
  • Lab monitoring services
  • Specimen management and storage services
  • Third-party laboratory management

Laboratory Testing: Another important component to supporting clinical development is through laboratory testing.  Test menus vary by company but include such categories as safety testing, immunoassay, flow cytometry, anatomic pathology, genomics, microbiology, bioanalytical, etc.  Some sponsors procure central laboratory services together with laboratory testing and include it in the same category, since all the testing is on the clinical trial protocol.  Some sponsors procure testing and central lab services separately, placing them in different categories. 

Patient Care Approaches Impacting Clinical Trails
  • Point of Care (POC) Testing in Clinical Trials:  POC devices are becoming more prevalent for patient care outside of clinical trials but are also gaining traction in clinical trials.
  • Virtual Clinical Trials:  The use of telemedicine, mobile device health tracking systems, and homecare have become more and more prevalent for patient care, and these same technologies are now being used in clinical trials.

Laboratory Science Digital Pathology: A system which provides ultra-fast scanning and high-resolution image would support a paradigm shift around centralized pathology review and reporting, easier access to specialized pathologists, and an improved adjudication process – with automated analysis and artificial intelligence to improve diagnostic accuracy and biomarker discovery.
  • AI Driven Pathology:  The first step toward AI driven pathology is fully digitizing the information. Over time the system will learn from pathologists and initially help to advise and QC.
  • Flow Cytometry:  With an exponential growth in the area of personalized medicine, and in particular immunooncology, companies are looking for innovative technologies that can provide high quality data with minimal variability, and continuous improvement efficiency initiatives to meet customers’ individual study needs.
  • Genomics:  The growth in the use of genomics in clinical trials is breathtaking as companies look to this new approach to develop and apply genome-based strategies for the early detection, diagnosis, and treatment of disease.

Sample Tracking 
  • Sample Tracking Systems: With ever more complex testing and the growth in volume of oncology studies, comes ever more complex data reconciliation and the need for more sophisticated sample tracking systems.  Sponsors have also identified the need to better understand the samples they have in various storage locations and the allowed use of these samples in the future.
  • Blockchain: Sponsors and Contract Research Organizations (CROs) are evaluating blockchain technology to potentially address patient privacy concerns around patient recruiting and study conduct.

Artificial Intelligence (AI)
  • Predictive Analytics: As described above, AI can be applied to digital pathology to improve diagnostics.  Work is ongoing to examine utilization metrics and habits around sponsor and site portals to drive improvements.
  • Operational Forecasting: Having more digital information available and implementing machine learning can help improve forecasting around kits, reagents, instrumentation, and staffing.

Q2 Solutions is a leading clinical trial laboratory services organization with bioanalytical, genomics, vaccines, flow cytometry, anatomic pathology, immunoassay, companion diagnostics and central laboratory services with secure, enterprise-wide biospecimen and consent management solutions