Dr. Robert Heinz & Partner GmbH and its 100% subsidiary, the CW Research & 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 wellestablished 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 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 noninterventional 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 wellestablished 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.’