OnkoDataMed, a specialist contract research organisation (CRO) providing remote data-capture solutions to dermatological, urological and gynaecological oncologists, has joined Medis Research Group, the Berlin-based clinical-research alliance set up last year in Germany.

Medis Research Group was established in November 2013 by ICRC-Weyer, whose services include data management, biostatistics, monitoring and medical review at all stages of clinical development, and Allied Clinical Management, which specialises in planning, management and on-site monitoring of Phase I to Phase IV trials.

Both companies are Berlin-based CROs, as is OnkoDataMed. Prior to forming Medis Research Group, ICRC-Weyer and Allied Clinical Management had worked together on a number of clinical-research projects, with Allied Clinical Management handling trial conduct, site management and monitoring, and ICRC-Weyer ‘back-office’ functions such as clinical-data management, biostatistics and medical writing.

The rationale for Medis Research Group was to address trial sponsors’ need for one-stop-shop solutions that could offer comprehensive service solutions across all stages of the clinical-development process.

Oncology network

With the added expertise of OnkoDataMed and its network of oncology trial sites, the Group can now tap into one of the largest epidemiological and clinical oncology databases in Europe, with information on thousands of patients currently receiving treatment – “a valuable source for retrospective data analysis”, it noted.

“Having access to hundreds of thousands of comprehensively documented oncology therapy cycles forms the basis for retrospective and prospective longitudinal studies which we can use to guide the market launch of a sponsor’s new product,” explained Michael Roehl, managing director of Allied Clinical Management.

The Group can also perform cross-analyses of data parameters drawn from its network of oncology practices in Germany, added Professor Dr Geerd Weyer, founder and managing director of ICRC-Weyer.

As of January 2014, he added, this network included more than 220,000 patients undergoing hormone therapy for prostate carcinomas, over 135,000 gynaecological oncology patients and more than 10,000 uro-oncology patients undergoing chemotherapy each year.

In addition to its network of over 500 dermatological, urological and gynaecological oncology practices in Germany, Medis Research Group has been undertaking site management and monitoring of Phase Ib to Phase III trials in more than 20 leading university clinics specialised in colorectal, breast and pancreatic cancers in Germany, Austria and Switzerland.