Avenue Saint-Hubert 51
Dr. Ingrid Klingmann, MD, PhD, FFPM, FBCPM
Managing Director at Pharmaplex bvba
Phone: + 32 2 784 36 93
Fax: + 32 2 784 30 66
The LENA Team
Dr. Lucie Spatenková
Phone: +49 157 565 143 14
Network of National Study Monitors
The team of local monitors are being appointed in the United Kingdom, Belgium, the Netherlands, Austria, Serbia and Hungary.
Pharmaplex bvba, a Belgium-based small and medium-sized enterprise, is a consulting company specializing in medicines development planning, clinical trial management, and site management support. The scope of projects performed by Pharmaplex in the 11 years of its existence include preparation of clinical development plans for small and medium-size non-EU pharmaceutical and biotechnology companies and European academic institutions wanting to develop their drugs in Europe, organization of Scientific Advisory meetings with EU and national competent authorities in the EU, identification of suitable countries and sites to execute the clinical trials, preparation of protocols and other study-related documentation, obtaining study authorization from competent authorities and ethics committees, project management of small and large multicentre, multinational Phase I to IV trials, coordination of site support to improve site efficiency, and writing of final reports.
Based on Dr. Ingrid Klingmann’s 30 years of experience as medical advisor in the pharmaceutical industry as well as her senior management roles in international CROs, Managing Director of a large university-based clinical trial site and as Medical Monitor in large international clinical trials, Pharmaplex is regularly asked to manage particularly complex trials or to rescue trials that have overrun timelines and/or budget. Pharmaplex manages and supervises trials through a study- adapted network of highly experienced national freelancers, consultants or small CROs working in several complementary roles (e.g., as project manager, monitor, study coordinator, medical monitor or medical writer) under umbrella contracts with Pharmaplex according to the requirements of the individual studies. Pharmaplex places special emphasis on efficient site management by providing study-specific training in applied GCP, efficient recruitment and site management as well as identification and support of specific site needs.