GHP April 2017

24 GHP / April 2017 , 1703GH08 Creating Success Together Dr. Robert Heinz & Partner GmbH and its 100% subsidiary, the CWResearch &Management GmbH, are an independent Contract Research Organization (Expert-CRO). Owner Christian Wolflehner tells us more about the firm’s specialisms and the services it provides to consumers. “We provide services for the pharmaceutical, biotechnology, medical device and healthcare industry. Over the years, in close cooperation with our customers, we have developed a broad service portfolio which allows us to develop tailor-made solutions for each project. It is our aim to provide our clients with an all-inclusive concept as well as individual services. We have made it our business to develop products even for the smallest niche. If our clients are in need of a specialised service for their project, they can be sure that we will find the perfect solution for them.” The team of experts at the organisation is highly motivated, dedicated and offers many years of experience. It is currently responsible for the implementation and management of numerous projects throughout Austria, Germany and Switzerland. In collaboration with its partners, Dr Robert Heinz & Partner has implemented projects in many other countries as well. “Reliability and trustworthiness, combined with a strong believe in business at a personal level, are the basis of our corporate philosophy and our success,” says Christian. “After all, quality is not an accident.” The company was founded in 1993 by Dr Robert Heinz in Vienna. “From small beginnings we have grown into a well- established company with nearly 25 years of experience in the field of clinical research,” Christian explains. Since 2007 the company has been successfully managed by Christian Wolflehner. This was also the start of the company’s early expansion. In the same year the opening of a second geographically favourable location in Adlwang/ Upper Austria followed. After the acquisition of the firm by Mr. Wolflehner in 2010 a restructuring took place which is responsible for the modern and flexible team that partners can rely on today. “Our expansion efforts continued in 2013 with the opening of an office in Germany and the foundation of our 100% subsidiary CW-Research & Management GmbH in Munich,” Christian Wolflehner states. “From industry leaders to small start-up companies, we tailor all our services to the needs of our clients. Each new project is unique in its structure, objectives and requirements. Therefore we became experts for individually adapted solutions - individuality rather than uniformity.” “Through continuous training of our team members we ensure a constant flow of new information. This gives us the possibility to always take new trends and regulations into account and to update our portfolio accordingly.” The services that Dr Robert Heinz & Partner GmbH provides can be grouped into five specific categories. Studies – Planning/ Monitoring/Evaluation Reliable study management during the entire cycle of a clinical or non-interventional study is the key element for a successful trial. The firm offers reliable support to both the sponsor and the study team on site. Its experience ranges from trials for pharmaceuticals to medical devices during all phases (Phase I-IV). In recent years, the amount of regulatory requirements for non-interventional, post authorisation safety and post marketing observational studies has increased significantly. The quality of their outcome is directly related to the quality of their conduct. “This is why we offer a full service package from first design to evaluation in order to guarantee a successful completion in accordance with all legal requirements,” says Christian. “One of the most important elements of trial management and evaluation are biometrics and data management. The quality of these two processes is responsible for good and reproducible results. Our highly experienced statistical personnel can offer their support in both areas.” “Our study management services also include the coding of medical data (MedDRA, ATC, WHO, etc.) and medical writing. We are pleased to provide our customers with abstracts, publication manuscripts, posters, newsletters and so on.” Data Collection To capture the data of a clinical trial or a non-interventional study the company can provide customers with many options in order to create the right system for them, and offers conventional methods like hardcopy CRFs (case report form) as well as more advanced electronical solutions. “For example we can set up a study database in combination with a completely traceable and validated eCRF. The systems we use fulfil all essential requirements and the collected data is hosted in Germany.” Pharmacovigilance While conducting a clinical study patient safety is of central importance. Therefore systems for ongoing safety monitoring should be put in place. The firm can provide clients with a broad spectrum of services to assist them in fulfilling their safety obligations. Offering everything from AE / SAE management to SUSAR-reporting and DSUR/ PSUR preparation. Audit – GCP / GDP / GMP Given the manifold of required standards that apply to the