BiRDS Pharma GmbH utilizes in-house skills and processes in drug development strategy and implements them through experienced partner companies or institutions specifically chosen for their expertise in the area of need. BiRDS Pharma GmbH operates within an established network of experts within and outside the BDD/CDRD Group. Whereas practical conduct of chemical, pharmaceutical, preclinical and clinical development is outsourced to validated contract manufacturers, contract research organisations, universities, and other research institutions, the overall management of the development project is under tight control by BiRDS Pharma GmbH. For each project a 'virtual' team, consisting of multiple partners led by one of our project managers is constructed based upon the project requirements. Each team is tailored to complement our internal resources to give maximum productivity. This model allows efficient use of capital by largely avoiding fixed resources. The use of the extended networks of partners gives rapid access to expertise, technologies and facilities that best fit the particular requirements of the development project. Through partnering with multiple suppliers the over all level of risk of the projects and the overall development costs are reduced.

BiRDS Pharma GmbH applies a Drug Development Scheme developed within the BDD/CDRD Group which has been optimized with respect to the efficiency of the drug development process. This scheme is reflected by corresponding tools for project management and is embedded into an IT infrastructure which allows for interconnection of different data and information streams. These structures have been used successfully for own drug development projects as well as for services in the area of project, data, and document management. The drug development process is divided into consecutive phases (periods) according to milestones which each consist of one or more study blocks. At each milestone the project is analyzed and evaluated for further progression. The development process strictly focussed on the formation of data, results, reports and documents according to the structure of the eCTD format. All databases are prepared to be exported into XML-format and thus allowing both smooth transfer to the partner as well as to the authorities for electronic submission.

The process of drug development based on the BiRDS Pharma GmbH´s Drug Development Scheme is embedded into a workflow, which is reflected by corresponding project management tools. Thereby data, documents and communication are canalized and knowledge and processes can be controlled centrally. Additionally, there are direct connections to databases as well as to tools for planning, controlling, and reporting. The enhanced efficiency of information retrieval and processing leads to an optimization of processes during management of drug development projects. BiRDS Pharma GmbH uses an extensive database system for administration, organization of drug development processes, and management of data, documents, and recourses. Consequential gathering of all data in inter-coordinated databases not only facilitates the actual work processes but in particular also aims at efficient compilation and structuring in eCTD format of the documentation required by the authorities for an approval for market authorization.