More details on Cetero/PRACS implosion come to light

By Zachary Brennan contact

- Last updated on GMT

More details on Cetero/PRACS implosion come to light

Related tags: Bankruptcy

Lachman Consultants has revealed more of the story behind the decline of the now bankrupt CRO Cetero/PRACS, which even though it’s shuttered, is still dealing with the fallout from its data integrity issues.

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​.”

Background

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.

Related news

Show more

Related products

show more

Overcoming Challenges of Clinical Data Review

Overcoming Challenges of Clinical Data Review

PerkinElmer | 10-Jun-2021 | Technical / White Paper

Clinical data review is intrinsic to clinical development, assuring patient safety, determining drug efficacy, and assessing data quality. It involves...

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Formedix | 09-Jun-2021 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Related suppliers

Follow us

Products

View more

Webinars