The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.

The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO-Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.

Stephanie Cape | Roger Hayes | Jennifer Zimmer | Patrick Bennett | Zhongping John Lin | John Kamerud | Afshin Safavi | Natasha Savoie | Paul Rhyne | Steve Lowes | Daniel Tang | Yansheng Liu | Laura Cojocaru | Bruce Stouffer | Chris Beaver | Rafiq Islam | Nicola Hughes | Eric Thomas | Nicola C Hughes | Corey Nehls | John Allinson | James Hulse | Masood Khan | Shane Karnik | Maria Cruz Caturla | Adriana Iordachescu | Luigi Silvestro | Rabab Tayyem | Ron Shoup | Stephanie Mowery | Anahita Keyhani | Andrea Wakefield | Yinghe Li | Javier Torres | Philippe Couerbe | Ardeshir Khadang | James Bourdage | Kayode Awaiye | Brent Matthews | Saadya Fatmi | Rhonda Johnson | Christina Satterwhite | Mathilde Yu | Jenny Lin | Michele Fiscella | Kai Kurylak | Wei Garofolo | Mike Buonarati | Nadine Boudreau | Clark Williard | Dominic Warrino | Prashant Kale | Neil Adcock | Radha Shekar | Edward O'Connor | Hanna Ritzen | Christina Sanchez | Mohammed Bouhajib | Simona Rizea Savu | Edward Tabler | Jing Tu | Chad Briscoe | Barry van der Strate | Phyllis Conliffe | Ira DuBey | Jim Yamashita | Elizabeth Groeber | Jenifer Vija | Michele Malone | Mohamed Osman | M. Fiscella | E. Groeber | Rafiq Islam | Daniel Tang | P. Bennett | R. Hayes | R. Tayyem | J. Allinson | I. DuBey | Mike Buonarati | Natasha Savoie | Chad J Briscoe | L. Silvestro | P. Kale | R. Shoup | M. Bouhajib | P. Rhyne | B. Stouffer | L. Cojocaru | Jennifer S D Zimmer | Chris Beaver | John Kamerud | Afshin Safavi | J. Bourdage | M. Caturla | S. Lowes | Z. Lin | Andrea Wakefield | P. Couerbe | J. Vija | C. Williard | Stephanie S Cape | Yansheng Liu | A. Iordachescu | C. Satterwhite | S. Savu | Stephanie A. Mowery | Nadine Boudreau | Ardeshir Khadang | Mathilde Yu | Jenny Lin | Wei Garofolo | H. Ritzén | E. Tabler | S. Karnik | Jim Yamashita | Neil Adcock | Jing Tu | Eric Thomas | Kayode Awaiye | A. Keyhani | R. Shekar | Michele Malone | Masood U. Khan | Yinghe Li | E. O'Connor | S. Fatmi | C. Sanchez | Phyllis R. Conliffe | Dominic Warrino | J. Hulse | Corey Nehls | Javier Torres | Brent Matthews | Rhonda J. Johnson | Kai Kurylak | Mohamed Osman | L. Silvestro†

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