Current Regulatory Guidelines for Human Biospecimens & Patient Consent in Clinical Research

Biomarkers, Clinical Trials, Life Sciences, Patient Recruitment and Retention, Pharmaceutical, Pharmaceutical Regulation ,
  • Wednesday, July 11, 2018

A biomarker-driven, precision medicine-based approach is becoming more prevalent in drug development and associated clinical trial design. Since biospecimen-derived biomarker measurements determine patient segmentation and endpoints in these trials, accurate biospecimen (sample) lifecycle management and real-time consent reconciliation are critical considerations in successfully meeting the outcomes of clinical development projects.

In this webinar, the speakers will summarize and discuss key regulatory requirements for consideration as your organization designs, conducts, and submits clinical trial based research.

Key takeaways include:

  • There are multiple regulatory sources that provide guidance and rules on patient samples and consents in clinical development
  • Compliance is one of many complexities around patient samples and consents
  • Patient-centricity and advocacy: how to apply balance between patient protection and still be ready for new opportunities in drug development

Speakers

Lorrie Divers, President, QRCP Solutions

Lorrie D. Divers has thirty years of experience in clinical research and development, including monitoring, clinical project management, regulatory compliance, training, auditing, quality assurance, and quality management in the pharmaceutical, biologics, vaccines, medical device and central service provider sectors. 

Prior to establishing QRCP Solutions, Inc. in 2017, Lorrie held director and executive director level positions in a global central laboratory and was responsible for all quality assurance and regulatory compliance activities for global clinical trials and commercial laboratory operations. She has previously worked in GCP quality assurance, procedural compliance and training roles for Bausch + Lomb and Wyeth Vaccines, as well as other clinical research roles for Bristol Myers Squibb, the University of Rochester, and Roswell Park Cancer Institute. 

Lorrie has successfully managed numerous regulatory authority inspections at sponsor facilities, investigator/study sites, and the clinical laboratory. She has presented at local and national conferences on a range of GCP and quality management topics and previously served as a member of the AIDS/Oncology IRB for a large academic medical center.

Message Presenter

Mark Engelhart, Chief Commercial Officer, BioFortis

Mark Engelhart has more than 25 years’ experience within the pharmaceutical and drug development industries, with extensive experience in sales, marketing, strategy, and global commercial operations. He has held commercial and general management roles across the continuum of drug development and commercialization, from pre-clinical and clinical development through post-approval marketing and sales. Mr. Engelhart is currently the Chief Commercial Officer at BioFortis, the leading provider of Biospecimen Lifecycle Management technology and services in the clinical research and development domains.

Message Presenter

Who Should Attend?

Sponsor, CRO, and Lab personnel including those with the following job functions:

  • Therapeutic Area / Program Head
  • Study Director
  • Clinical Operations
  • Biomarker Operations
  • Translational Medicine

What You Will Learn

  • There are multiple regulatory sources that provide guidance and rules on patient samples and consents in clinical development
  • Compliance is one of many complexities around patient samples and consents
  • Patient-centricity and advocacy: how to apply balance between patient protection and still be ready for new opportunities in drug development

Xtalks Partner

BioFortis

BioFortis is a leading provider of clinical development technology solutions & services, which empower total biospecimen lifecycle management. Its flagship product, Labmatrix, provides clinical trial sample & consent tracking, study subject & biobank management, and sophisticated data management capabilities leveraging the full potential of patient and sample-related information. With enterprise-level capabilities for integrating eClinical and bioresearch data collections in a harmonized, tightly-linked, and regulatory-compliant manner, Labmatrix enables its users to easily ask sophisticated ad hoc questions and generate insights, reports, and dashboard visualizations.

For more information, contact us at info@biofortis.com, visit http://www.biofortis.com, or follow BioFortis on LinkedIn https://www.linkedin.com/company-beta/140874/.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account