GHP April 2017

26 GHP / April 2017 , field of medical research it is important to evaluate processes and workflows. “Our certified auditors will be glad to review quality management systems and other quality-related activities, helping our customers to identify possible risk factors and giving them the chance to implement cost- and time-saving solutions.” SOP – Preparation/Review/ Management Standard operating procedures play an important role in quality and risk management. SOPs help to minimize reoccurring mistakes and provide a firm basis for all safety-relevant tasks. They are essential for the implementation and maintenance of quality and risk management systems. “We can help our clients in developing their own SOPs, tailor-made for their needs, or provide them with our own proven master SOPs.” When the organisation started nearly 25 years ago the approach to clinical and non- interventional studies was quite different. Over the years the requirements and regulations have grown both nationally and internationally. Christian comments: “We - Dr Robert Heinz & Partner - made it our business to grow with these increasing challenges in order to be able to support our customers accordingly. In the recent past we also began to expand our business operations in Austria and Germany by opening offices in Adlwang and Munich. In addition to geographical expansion we constantly develop our services and product portfolio in close cooperation with our clients. Today we are a well- established and experienced CRO with a constant drive for innovation.” Dr Robert Heinz & Partner may be a huge success, but Christian tells us that the firm wouldn’t be what it is today without the support and dedication of a top-notch team of experts at the helm. “Our team is our greatest asset,” he enthuses. “Their know-how is the key element of the success of our company. Project-orientated and efficient working, accuracy, reliability, global and cross-linked thinking are just some characteristics of our employees. Besides their professional skills the individual personalities of our team members ensure working on a personal level. This ensures smooth cooperation with our clients. Through continuous education and training we keep the knowledge and abilities of our employees up-to-date. In addition to our full-time employees our team also comprises of external experts, with whom we have worked together closely and successfully for many years.” The success of the firm ultimately lies within the testimony of its customers, and Christian tells us of the close and productive relationship it has with clients. “We believe in doing business on a personal level in order to minimize bureaucratic and administrative hurdles. To guarantee customer satisfaction and to improve our services we use a feedback form for all our projects. The form is handed out to the operational staff at the study site e.g. the principal investigator or a study nurse, as well as the responsible personnel at the sponsor. Evaluating these responses gives us a very good feedback on the way we handle our projects and tells us exactly if there is a need for improvement.” The pharmaceutical and biotechnological industry is faced with rapid technological changes, new regulations and safety requirements. In general clinical trials and non-interventional studies will become even more complex over the next few years. “We - Dr Robert Heinz & Partner GmbH - see these changes as an opportunity for innovation and development.” “For instance, many recent regulatory developments opened up the opportunity to implement new ways of risk-adapted quality management – e.g. risk-based monitoring. We can help our customers to identify the most critical parts of their trial and improve their design if needed in real time. We can also help them with creating standard operating procedures (SOP) to streamline their processes.” In addition clinical trial management stands at the forefront of many technological advances. Modern technology makes direct and long term data capture very easy. It allows Dr Robert Heinz & Partner to gather more information about safety and efficacy than ever before. “Another important trend is cloud computing. It will make us more flexible and will give our customers new ways to interact with patients and principal investigators.” “On the other side we will also have to face new challenges like the correct handling of generated data or the implications for data privacy. This is where we come in with our long-time experience. Together with our network of long-term partners we are going to develop tailor-made solutions for our customers, whatever the future holds.” Despite these challenges, Christian Wolflehner has goals and aspirations for continued growth and success, with regards to the short and long term future. “Our next goal for the near future is the expansion of our efforts in Germany and other countries,” he states. “We have already established a close network lof partners, national as well as international, and would like to consolidate and further develop these relations.” “We are already very experienced in working closely with partner companies during the management of multinational studies. Furthermore our focus lies on rapid adaption to new requirements and challenges in clinical trial management, so we can always offer an up-date service portfolio to our clients.”