Avoca invites CROs to join Pharma sponsors in Quality management debate

31-Jan-2012 - Last updated on 31-Jan-2012 at 11:03 GMT

Related tags Contract research organization

Sponsors want CROs to join the debate on quality management in clinical research says the Avoca Group, which has invited contractors to sign up to its recently established industry consortium.

The consulting and research survey firm launched the consortium last year in a bid to bring Sponsors and contract research organisations (CROs) together to develop a set of quality management standards and agreements that could be used by the whole industry.

To date sponsor members like Pfizer, GSK, AstraZeneca and Eli Lilly have provided information covering their – often differing - approaches to management and oversight, ranging from the metrics used for outsourced trials to the agreements and templates they use with CROs to document quality expectations.

The aim now is to start asking CROs to join the consortium - in parallel to ongoing sponsor recruitment - to broaden the debate.

Avoca CEO Patricia Leuchten told Outsourcing-pharma that while signing up CROs had always been a goal, sponsor members' desire for contractor involvement prompted the group to start the process sooner than it had originally planned.

“We had the intention that we would work solely with the sponsor organisations in the first half of the year. As we are getting into the work and have more and more discussions with the senior executive of our member organisations they are expressing an interest in bringing CROs into the process much earlier.”

CRO recruitment

In response to these requests, Leuchten continued, Avoca is asking CROs to join and share their thoughts on the quality agreement template and metrics the consortium is developing to try and assess their implications for clinical research.

“The kind of input we are expecting is really a reality check on whether what the sponsors are expecting of CROs is really, one, realistic and, two, whether these things have cost implications” she said, explaining that this builds on the findings of Avoca’s recent industry survey.

“One of the things we identified in our 2011 report is that sponsors have high expectations of CRO and while the CROs in general think they are well placed to provide high quality…they don’t believe that sponsors are willing to pay for it at times.”

Confidentiality

CRO consortium members will also be asked to share their own quality metrics and measurement approaches to try and make any standards that are developed as robust as possible.

However, while the aim is to create an open debate, Avoca is not asking the senior executives they aim to recruit from CROs to share information with potential competitors.

“With all of our members we are treating all of the information we are receiving as confidential. We are signing contracts with each member so it would be the same for CROs,” Leuchten said adding that this would apply to the input they receive from contractors.

“We wouldn’t say – for example – well Covance feels strongly about this and Quintiles doesn’t. It’s really going to be handled very carefully and in the spirit of co-operation and not to single any company out and not to divulge any confidential information or specific processes that any company has.”

In addition to the research and analysis it will be doing in the coming months Avoca will hold a summit for Sponsors and CRO consortium members in New Jersey on May 1 and 2nd to present the results so far and prompt further in depth discussions.