German clinical development service organization, Accovion, uses SAS® solutions for faster drug approval and delivery

Accovion GmbH (formerly Covidence) is a clinical research and development service provider for pharmaceutical and biotechnological companies. At the request of its clients, Accovion plans and conducts national and international clinical studies which are used to prove the efficacy and tolerance of drugs – from the first clinical tests to the final marketing approval of the drug by government health authorities.

Accovion has detailed knowledge of the regulatory requirements in all areas of clinical development. Resulting from more than 20 successful approvals by the European as well as American regulatory agencies (respectively EMEA and FDA) based on hundreds of studies in more than 20 countries, Accovion has successfully established itself in the marketplace and has subsidiaries in Germany, France, and the United States. Subsidiaries in Eastern Europe are planned for 2005. Many employees at Accovion have worked with SAS since approximately 1980.

Accelerating release to market
Accovion takes charge of the complete planning and execution of clinical studies on behalf of its customers from the pharmaceutical and biotechnology industries – in some instances completing entire development projects for them. Accovion delivers the results of the studies or the marketing approval projects to its customers or, if required, submits them on behalf of their clients to the relevant authorities in Europe, the United States and Japan. A high level of teamwork and interdisciplinary cooperation between medical staff, statisticians and technical experts are required – both when planning and implementing a clinical study, as well as during its statistical evaluation and interpretation. Like 95 percent of all research-driven pharmaceutical companies, Accovion chose SAS for the statistical and biometrical evaluation of clinical study data – a testament to the power and flexibility that SAS solutions deliver.

For market approval applications, the integrated study data is collated in databases then evaluated, with the results being presented in summary documents. Accovion is currently considering the implementation of a Web-enabled solution in order to facilitate even more efficient, expedited communication between internal and external members of clinical study or project teams. Using this Web-based application, Accovion clients would have ready access to information about project progress and status.

Transparency and documentation of the data integration process, as well as the reproducibility of results by the authorities, play a crucial part. The analysis and summarization of clinical data can be significantly accelerated through the use of standards – resulting in earlier marketing approval of a drug and competitive impact, for which each day saved can represent potential sales revenue in excess of US$1 million (€779,000). Endorsed by the FDA, the Clinical Data Interchange Standards Consortium (CDISC) study tabulation model (SDTM) standard is expected to establish itself quickly as the industry standard for clinical data. Using standardized data models results in the exchange of data between all parties involved in a clinical study being simplified.

Accovion has implemented the latest CDISC standards – spanning from clinical data entry to the efficient generation of CDISC data sets, as well as the creation of standardized programs for the transfer of clinical study data from other formats into the most current CDISC structures.

Enhancing data aggregation through standards
The statistical services department at Accovion uses SAS for the development of programs that prepare and perform the statistical analysis of clinical data. All the programs that are used for the analyses are developed, documented and validated at Accovion according to the most stringent IT and regulatory standards. With the continuous enhancements of its SAS-based data analysis and reporting solution, Accovion continues to improve its services and delivers significant time gains to its clients.

In addition, Accovion offers its clients a standard data model based on CDISC for set up of clinical databases – which covers approximately 70 percent of the registry-relevant data. Accovion has also developed indication-specific solutions for important indications; for example, oncology or metabolic-related illness that address a further 15-25 percent of the approval-relevant data. Thus, the individual programming effort of a clinical study can be reduced significantly.

The use of the new CDISC standards also simplifies the subsequent aggregation of study data for the summary analysis within the context of a regulatory submission. Until now, a lack of standards has resulted in highly disparate data – with the work involved in data preparation and aggregation being very high. Addressing the complexities involved in this process and minimizing errors, Accovion has developed a new mapping tool in SAS that automates the manual aggregation of individual studies and thus achieves a significant increase in the reproducibility and acceleration of the process. As a result, the overhead of developing individual programs that transform various database structures into a standard format suitable for submission no longer needs to be addressed.

It is advantageous for Accovion's programmers that SAS has actively taken part in the development of international CDISC standards and provides support for them in its procedures. For example, data can be transferred efficiently into the CDISC transfer format via "proc cdisc". Furthermore, SAS also provides support for CDISC data models in its integrated data management solutions.

As the consolidation of the studies and the processes involved are significantly simplified, a reduction in effort and time spent can be realized in an area where adherence to authority requirements and highest quality is of uppermost importance. Due to the high flexibility of its SAS-based solutions and the integration of the new CDISC standards, Accovion is able to produce submission documents faster and easier, thus ensuring its clients benefit from significant time gains.

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