Max Neeman and QED boost CDISC offerings

29-Jun-2010 - Last updated on 10-Nov-2023 at 16:01 GMT

Indian CROs Max Neeman International and QED Pharmaceutical Services have both added US Food and Drug Administration’s (FDA) CDISC compliance to their data management offering this month.

New Delhi-based Max Neeman has developed a process that converts clinical data into the format the US drug regulator requires for electronic submission using SAS and SAS Clinical DI studio for mapping.

The idea is to make it more straightforward for Max Neeman’s customers to submit trial data to the FDA and is part of the CRO’s recent efforts to expand its data management and research business.

In March for example, Max Neeman partnered with German software firm Amedon to expand its electronic data capture (EDC) offering in line with market demand.

Amedon designed its system to ease data entry and capture at the site end, offer serious adverse event reporting alerts and allow for direct capture of laboratory inputs.

And, just last month, the CRO won a contract to manage clinical data from an ongoing Phase IV trial examining the benefits of switching to Aromasin from tamoxifen for post menopausal women suffering from breast cancer.

This deal was followed just a few weeks later by Max Neema’s decision to set up a central laboratory unit for clinical trial sample analysis.

Speaking at the time company CEO Ajoy Kumar explained that "We believe in continually expanding our service list… to provide accurate results in the shortest possible turn around time.”

QED Licenses SAS’ clinical data integration platform

In related news, earlier this month Hyderabad-based QED has licensed the SAS Clinical Data Integration platform from US software firm SAS to “accelerate analysis and decision making in clinical research.”

In a press statement QED founder Ramana Kuchibhatla said that: “The availability of SAS Clinical Data Integration has made it possible for QED to efficiently implement complex data standards such as the CDISC standards.

Dr Kuchibhatla added that: “Compliance with the latest CDISC standards makes growing drug developers like our clients very attractive partners to large pharma companies that are looking to in-license successful drug development programs.

“The overall value created by SAS Clinical Data Integration to both QED as a service company and our clients by making them attractive partners and ensuring regulatory compliance is tremendous.”