Centocor
Executive Summary
Contracts Bio-Pharm Clinical Services to conduct clinical data management and analyses of the biotech company's new Phase III trial required by FDA for Centoxin (HA-1A) in the treatment of septic shock patients ("The Pink Sheet" June 8, T&G-12). In addition, Centocor has hired the law firm of King & Spalding to audit all of the company's PLA filings "to ensure that procedures and protocols are in place to protect the integrity of clinical trial results and identify any deficiencies or discrepancies which may have existed in the past," Centocor said in a June 26 press release. Centocor's MyoScint PLA, recommended for approval in November, also appears to be stalled at FDA. The company has created a Compliance Oversight Committee reporting to the board of directors, which will "oversee the introduction and monitoring of compliance procedures within Centocor operations and to implement any recommendations resulting from the audits," the firm said.
Contracts Bio-Pharm Clinical Services to conduct clinical data
management and analyses of the biotech company's new Phase III
trial required by FDA for Centoxin (HA-1A) in the treatment of
septic shock patients ("The Pink Sheet" June 8, T&G-12). In
addition, Centocor has hired the law firm of King & Spalding to
audit all of the company's PLA filings "to ensure that procedures
and protocols are in place to protect the integrity of clinical
trial results and identify any deficiencies or discrepancies which
may have existed in the past," Centocor said in a June 26 press
release. Centocor's MyoScint PLA, recommended for approval in
November, also appears to be stalled at FDA. The company has
created a Compliance Oversight Committee reporting to the board of
directors, which will "oversee the introduction and monitoring of
compliance procedures within Centocor operations and to implement
any recommendations resulting from the audits," the firm said. |