The consulting firm, which is now working with the former CRO’s sponsor partners to obtain data from the CRO’s archives, says the issues observed at Cetero/PRACS “are not unique and could potentially occur at any CRO.”
In addition, the consultants compared the fiasco at Cetero/PRACS with Indian CRO GVK Biosciences' most recent investigation from the EMA over falsified data, as well as “alleged data integrity issues recently uncovered by FDA at many overseas generic pharmaceutical companies.”
In 2010, FDA issued an untitled letter to Cetero over significant concerns regarding the integrity of Bioequivalence and Bioavailabilty (BEBA) data generated over a five-year period. The agency found that some subject samples were manipulated to produce more desirable results, while time and date records were also falsified.
“It is interesting to note that these practices of using ‘prep runs’ and manipulating time and date records are very similar to recent FDA inspection observations of many overseas GMP analytical laboratories,” Lachman’s Frank Chow writes.
In 2012, prior to the completion of the FDA-mandated remediation activities, Cetero filed for Chapter 11 bankruptcy, changed its name to PRACS, and then in March 2013, PRACS unexpectedly ceased all operations and filed for Chapter 7 bankruptcy.
Former partners of PRACS panicked as they “not only had the need to gain access to their recent study records, test articles and subject specimens in support of their pending filings but also needed to gain possession of their archived study records, which were stored in various off-site locations in support of their approved/marketed and research products that were (and still are) under the control of the Court-appointed trustee.”
Work with Former PRACS employees
Lachman Consultants then worked with former key PRACS QA, clinical and bioanalytical employees as contractors to support the process of retrieving the sponsor property.
But the retrieval process was complicated when the last former PRACS facility in Fargo, ND -- where most of the recent study records were located -- was sold to a third-party in late 2013.
“Nevertheless, the current process will soon come to an end as the bankruptcy case winds down. The Court-appointed trustee has sent out notices to many former sponsors to inform them that their records will be deemed abandoned and destroyed if they are not claimed and to request appropriate timely actions from these sponsors,” according to Lachman.