Pharmacovigilance: safety becomes a principle
Tübingen-based CenTrial GmbH, established in 2000, is a provider and manager of clinical trials. Pharmacovigilance is an important segment of the company’s work: CenTrial supports its clinical trial clients in all phases of clinical drug development related to drug safety – up until the time a drug enters the market and beyond. The services offered range from the analysis of data to the complete design of the safety management process, including dealing with the regulatory authorities.
As a subsidiary of the university clinics of Tübingen and Ulm, CenTrial has close links with clinical and academic researchers. The majority of the company's clients are small- and medium-sized pharmaceutical companies. The large pharmaceutical companies tend to have their own clinical trial departments and graduated scheme officers who design and oversee safety processes. "Big pharmaceutical companies tend to outsource individual processes to us, while SMEs usually have no capacity at all for carrying out clinical studies and dealing with pharmacovigilance, which is why we support them throughout the entire process," said Prof. Dr. Christoph Gleiter, Managing Director of CenTrial GmbH.
"It is not the principal investigators of the trials who contract our services, but rather the sponsors of the trials. We become involved at different development phases of a drug according to the client's requirements. Sometimes we become involved in the early clinical phase, long before the drug under investigation enters the market for a specific indication. However, there are also cases where a drug that has already been granted marketing authorisation needs to be tested for a different indication or where clinical trials become necessary when the formulation of a particular drug is changed," said Gleiter. CenTrial also supports companies in post-marketing studies by offering services related to drug safety, added Dr. Martina Krampol, head of CenTrial's pharmacovigilance department.
All details must be correct and reproducible
A safety manual is prepared for all contracts. This is a plan that details who does what, when and in how much detail. "Achieving high quality results and findings from clinical trials is an elementary basis for ensuring progress in medicine. In addition, legal deadlines must be taken into account. For example, we need to fulfil certain reporting obligations," said Krampol. CenTrial has always worked very well with the regulatory authorities and ethics commissions, partly due to the fact that the company's staff is highly skilled at what they are doing and has a great deal of experience in dealing with official authorities. "In principle, the documents and files we submit are dealt with quickly and without delay," said Krampol.
As all drug trials have their own specific requirements, CenTrial prepares individual matrices, thus adapting the databases to the requirements of individual trials. "Our staff includes medical computer specialists, quality managers, clinicians and life scientists. Depending on the contract, we will set up a team that will remain the same throughout the entire process," said Gleiter.
Raising awareness, establishing understanding
CenTrial also provides their clients with comprehensive information about clinical trials processes and drug safety requirements. Sometimes clients take some convincing. "Some safety aspects are strictly regulated by the legislator, which is why complex processes become necessary which we have to communicate to our clients in a very comprehensible manner. It is very important for us to inform our clients about the legal conditions, individual problems and the processes required in order help them understand the overall process," said Gleiter who seeks to make his clients aware of certain drug safety aspects, because "the requirements are in the interest of the patients."
As it is not necessarily the legal basis that undergoes frequent changes, but rather the regulations and instructions, it is crucial for the CenTrial team to keep up-to-date. "We also need to continuously adapt our processes and documents," said Gleiter. Krampol added: "In many cases, there are transitional periods for ongoing studies that give us time to adapt our processes to altered or amended regulations." Keeping up-to-date with changes is a very time-consuming business. Innovative combinations of drugs and medical products, such as those created by tissue engineering, which refers to the cultivation of tissue in the laboratory, might prove very challenging. "It becomes very important for us to think about ways to implement these requirements and challenges into our processes," said Gleiter.
CenTrial not only deals with drug safety on a contract basis; it is also active in providing further training in the various areas involved in a clinical trial. The seminars offered are also suitable for inexperienced users who would like to get an overview of important issues and processes. CenTrial attaches great importance to communicating an understanding of the entire system. The new seminar dates will be published on the company's homepage in early 2011.
Prof. Dr. med. Christoph H. Gleiter
Tel.: +49 (0)7071 29-72262
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