Laboratory Considerations for Clinical Trials

This podcast from Q² Solutions looks at factors sponsors should consider when preparing for clinical trials.

With fewer people covering more roles with less specialization and novel therapeutics with unique testing requirements, the needs of small biotech companies in clinical trials are different from larger sponsors.

In this episode, Alex Watt, Global Head for Biotech Integrated Laboratory Solutions and Mona Henderson, Director of Laboratory Network Solutions (both at Q2 Solutions) discuss how our dedicated biotech teams focus specifically on the unique needs of those customers.

Alex and Mona cover:

  • Operational strategy, from supply chain to data management
  • The role of LNS in contracting and managing specialty, third-party labs
  • Collaboration with our parent company, IQVIA and
  • Adapting to evolving customer strategies 

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In this episode, Alex Watt, Global Head for Biotech Integrated Laboratory Solutions and Alan Wookey, Global Head of Companion Diagnostics discuss how to manage both scientific and operational risk in clinical trials for biotech companies.

Looking at risk as uncertainty reveals not only threats to project timelines but also opportunities to take a new approach. 

Alex and Alan talk about:

  • How different risks are evaluated and prioritized and the processes put in place to mitigate and/or respond to those risks if they occur. 
  • What sponsors can do to reduce the risks for their study
  • How Q2 Solutions' in-house scientific and regulatory expertise ensure that your data are compliant to global regulations

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Alex Watt is the Global Head for Biotech Integrated Laboratory Solutions at Q2 Solutions. In this episode, the first of a three-part series, he talks about how biotech companies can best prepare for testing with a CRO or clinical trial.

  • First it's important to understand you analytical needs. What services are needed to operationalize the study design?
  • Second is data, How will the data generated be used?
  • Third is logistics and supply chain. How does sample get to the analytical location and then to its final destination?

Alex goes in depth on each of these and also highlights a number of items that can be overlooked and cause delays as well as what is an appropriate lead time to begin conversations with your vendor to meet your company's timeline.

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Becoming bilingual in bioanalysis

In this podcast Barry Jones (Director, LC–MS Biologics and Biomarkers at Q² Solutions) and Adriane Spytko (Manager, LC–MS Biologics at Q² Solutions; both NY, USA) discuss hybrid assays using both LBA and LC−MS techniques. They share their thoughts on bottom-up LC−MS methods and the concern about detecting analyte that is not intact as well as future projects that bridge LC−MS and LBA.

Most clinical trials involve a variety of laboratory vendors and CROs to provide services during the course of the study. Disparity in how each vendor handles, tracks and reports its data can present a challenge.

In this episode, Barbara Nagaraj, Senior IT Architect at Biofortis, a Q2 Solutions company, describes those challenges and how to mitigate them by asking the right questions in advance.

She talks about:

  • The need to harmonize data moving between systems
  • How to approach vendors of different sizes and capabilities
  • The best time to engage a vendor about data management
  • Questions to be answered in negotiations
  • A success story that save a lot of time and effort

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Taking an assay from bench to an automated platform

In this podcast, Prakash Bhosale (Director of Discovery ADME at Q2 Solutions; IN, USA) discusses high-throughput in vitro screening and how to understand structure-activity relationships against ADME properties. The advantages of the Tecan technology are also addressed as well as top tips for driving SAR analysis.

Questions discussed include:

  • Why is compound management and storage important?
  • Do you suggest that a lab goes full in on automation or transitions to automation over time?
  • When do you take an assay from the bench to an automated platform?
  • How much experience do you need with programming to implement automated tools?
  • What are the advantages of the Tecan technology?
  • What are your top tips for driving SAR analysis?

In this podcast interview, Jason Evans (Scientist at Q² Solutions) discusses the importance of automation and key advantages of taking an assay from the bench to an automated platform. He also explains the increase in throughput when his lab transitioned to automated assays and the hurdles he faced when automating assays.

Tracking patient consent for the use of their samples in clinical trials is essential to both minimize risk of non-compliance and maximizing potential for future use. 
In this episode, Barbara Nagaraj, Sr. IT Architect at BioFortis, a Q2 Solutions company, explains informed consent for patient samples and the importance of easily tracking consent as samples move through the clinical trial ecosystem. 


She describes:

  • How consent is or has been documented
  • The benefits of electronic consent documentation
  • Specific consent attributes, e.g. genetic testing
  • Handling consent requirements from different countries or institutions
  • Understanding consent for future use, including limitations and expirations

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The clinical trial ecosystem is a complex web of investigator sites, laboratories, couriers, patient samples and more.  The ability to track those samples though this ecosystem with full visibility for the sponsor is essential for a successful trial. In this episode, Barbara Nagaraj, Sr. IT Architect at BioFortis, a Q2 Solutions company, describes that ecosystem and the lifecycle of patient samples. 


She describes:

  • The varying approaches of small vs. large laboratories
  • Risks of insufficient tracking
  • Tracking consent for future use
  • Current practice and opportunities for improved tracking

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In this episode, Charlie Fix, Global Director of Scientific Harmonization for Q Squared Solutions describes the challenges of safety testing for drugs in pediatric patients where sample volumes may be limited.

Clinical analyzers are set up to maximize throughput and minimize turnaround time. When a panel of multiple tests is ordered and a sample doesn't have a sufficient volume of blood to run all the tests in the panel, the test is canceled, resulting in no data for the sponsor and unnecessary stress for young patients and their families.

Q Squared Solutions has developed a protocol prioritizing a subset of tests for short samples. The decision to run the alternate panel is made by licensed medical technologists. Combined with specific sample collection kits for pediatric patients, this protocol minimizes the number of canceled tests.

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