Sponsor/contract laboratory communication: a team approach to quality.
The true measure of any successful quality endeavor is the final product. The final product generated at contract facilities conducting nonclinical studies is the final report. This should be accurate, complete, and consistent with regard to the raw data, and in compliance itself. The final report resulting from studies conducted at contract laboratories should be reflective of the collaborative efforts of sponsor and laboratory staffs. The dual interaction of the respective Quality Assurance Units (QAUs) in ensuring that optimal study performance is maintained from initiation through final report submission is of paramount importance. Key to any productive sponsor/contract laboratory relationship is communication. The multidirectional flow of information inherent in the conduct of nonclinical studies must be managed to maximize the strengths of the principals involved, while at the same time assuring that consistent emphasis is placed on team focus. Although the role of the QAUs representing the contract facilities and the sponsor both ensure the quality of study conduct, and ultimately the final product, their respective approaches may be from different perspectives. The contract QAU's primary focus is the specific study conduct, including appropriate inspections of ongoing critical phases and audits of raw data and reports, along with compliance to site Standard Operating Procedures (SOPs), protocols and sponsor requirements. On the other hand, sponsor QAUs focus mainly on overall study conduct, assurance that contract QAUs are operating effectively, and ensuring that sponsor monitors are communicating adequately with contract facility personnel. Open communication between the respective QAUs is the most productive and useful way of ensuring that all quality criteria are met.(ABSTRACT TRUNCATED AT 250 WORDS)
Caulfield
M
M
Bio/dynamics, Inc., East Millstone, New Jersey 08875-2360.
Franklin
W
W
Muncie
J A
JA
Nelson
J
J
Ross
T
T
Russo
A S
AS
Schulte
M C
MC
Sottolano
L A
LA
Vincifora
C J
CJ
Pappacena
B M
BM
D002985:Clinical Protocols; D003142:Communication; D003284:Contract Services / Q000458:organization & administration*; D007373:Interinstitutional Relations; D007753:Laboratories / Q000592:standards*; D009937:Organizational Objectives; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D012109:Research Support as Topic / Q000458:organization & administration*