The alliance will grant PPD access to the hospital’s clinical trials management unit (CTMU) and aims to improve access to commercial clinical research for patients, accelerate the development of new medicines and enhance health care treatment opportunities for Germans.
PPD will work with the CTMU to shorten trial start-up times, maximize the number of patients recruited for trials, generate high-quality data and ensure all site staff members are trained as necessary.
Roger Newbery, PPD’s VP of clinical management for Europe, Middle East and Africa told Outsourcing-pharma.com “this collaboration enhances our support for our clients in expanding their research programs in Germany and around the world, and will enable us to gain efficiencies in one of our most frequently used investigative sites in Germany.”
With offices in Munich, Karlsruhe and Nuremberg, PPD’s team of more than 400 professionals in Germany offers expertise in biostatistics , clinical management, data management , pharmacovigilance, project management and quality assurance .
“We remain committed to running studies in the US,” Newberry told us. However, the company has also grown its presence “significantly in Asia Pacific and continue to expand our depth of capabilities. PPD has opened offices in Kenya and the Slovak Republic, and added staff and services across multiple PPD locations in Central and Eastern Europe to meet clients’ needs.”
The collaboration builds upon the long-standing relationship between PPD and the Charité, one of the largest and most well-respected university hospitals in Europe. With 13,200 employees, the hospital maintains more than 100 clinics and institutes within 17 centers at its four campuses.
“By extending our relationship with PPD, our aim is to ensure improved access to novel medicines and advance our mission of securing lasting health improvements for our patients,” said Gerrit Fleige, executive director, finance and administration of the medical faculty of the Charité–Universitätsmedizin Berlin.
New disease areas
The agreement includes a wide range of Phase I-IV trials across multiple therapeutic areas . Key focus areas for the CTMU include hematology/oncology, cardiovascular, neurology, psychiatry, respiratory, rheumatology, anesthesia, dermatology, nephrology, urology and women's health.
“Through strategic partnerships with our clients we have a strong understanding of the pipeline of trials that are likely to be outsourced. That enables us to proactively plan site relationships based on the anticipated business,” Newberry added.
“These relationships might be specific to a particular therapy area if we anticipate significant business in that area over the next couple of years or these relationships could be with groups that are able to deliver a number of different therapy areas for us or in particular geographic areas.”