Memberships & Accreditations

METRONOMIA is a member of numerous associations and organizations related to Clinical Data Management, Biostatistics, and Medical Writing. This allows us to keep up to date with the latest developments in the industry and help advance data science in clinical research.

Below you will find an overview of METRONOMIA's memberships and accreditations.

BVMA (Bundesverband Medizinischer Auftragsinstitute e.V.) - Federal Association of Contract Research Organisations

The BVMA was founded in July 1991 in order to represent CROs (Contract Research Organisations) which are based in Germany or German speaking countries. The BVMA is based in Munich.

At present 49 companies, operating in the field of clinical research at a national as well as international level, are members of the Association. This means that the member companies with their approximately 8.000 employees represent more than 80% of the employees in the German CRO market.

For more information about the BVMA, visit: www.bvma.de

ACDM (Association for Clinical Data Management)

ACDM represents enthusiastic clinical research professionals with a passion to improve the drug development process by offering an environment for continuous learning and application of contemporary Clinical Data Management practices. Serving the data management community for over 30 years, the ADCM’s commitment is to provide explicit settings for fellow members to network, share experiences & keep up to date with the latest regulations & standards in the area of Data Management. THE ADCM also take pride in helping their members in their professional development journey. The mission is to provide opportunities to constructively engage, collaborate and learn from the industry experts in Data Management, to equip members with the necessary skills to excel in their careers, so they can become the data management experts of the future.

For more information about the ACDM, visit: acdmglobal.org

BioM

BioM has been the development and management organization of the Munich Biotechnology Cluster since 1997. The BioM Cluster encompasses the Greater Munich area and today includes around 450 biotechnology and pharmaceutical companies as well as associated service providers. The core competence of the region is the development of innovative therapeutics, diagnostics, and underlying technologies, especially for personalized medicine. In total, BioM has supported more than 250 start-up companies over the last 25 years. In addition, BioM offers a variety of workshops, trainings and events on industry-specific topics.

METRONOMIA is a member of the Bavarian Biotechnology cluster.

For more information about Bio M , visit: www.bio-m.org

CDISC

CDISC is a 501(c)(3) global, non-profit charitable organization that brings together a community of experts from around the world to develop and advance data standards of the highest quality that create clarity in clinical research. This community enables the accessibility, interoperability, and reusability of data for more meaningful and efficient research that has greater impact on global health.

Clear data is essential to the success of research and the development of new treatments and therapies. But far too often this data remains confined to one organization or one moment in time. When CDISC standards are applied, data is collected, organized, and analyzed in a clear and consistent manner so that all researchers can leverage and share information from individuals and studies around the world.

CDISC takes a rigorous approach to developing and advancing data standards for clinical research and beyond. Each standard is informed and shaped by the expertise of those at the forefront of research today, making them not just of the highest quality, but also attuned to the practicalities of their implementation.

The suite of CDISC standards is freely available on the CDISC website. CDISC standards have been, adopted and implemented in over 90 countries, and are required by regulators in the United States (FDA) and Japan (PMDA) for drug submissions and recommended by the China National Medical Products Administration (NMPA).

CDISC is funded through the generous support of over 500 member organizations as well as through grants, authorized Education courses and CDISC events.

Judith Köppert, Senior Statistician at METRONOMIA, is also member of the Steering Committee of the German CDISC User Network.

For more information about CDISC, visit: www.cdisc.org

DVMD (Fachverband für Dokumentation und Informationsmanagement in der Medizin e.V.) / The Association for Documentation and Information Management in Medicine

Since more than 50 years, the DVMD represents the interests of all professional groups in documentation and information management in medicine. It is a network with 800+ members, has extensive expertise and many years of experience in medical information management, and creates commitment and networking between people and professions. It is the interface of a diverse and in part still relatively young specialist field, which essentially comprises four specialist areas: Epidemiology, tumor documentation, clinical research and clinical documentation in hospitals.

For more information about the DVMD, visit: www.dvmd.de

DGPharMED

DGPharMed e.V. is a scientific-medical society for physicians, scientists, university graduates and other professionals in pharmaceutical medicine. The members are active in the pharmaceutical industry and medical technology as well as in clinics, medical practices, CROs and other scientific facilities or institutions.

As a multidisciplinary field, pharmaceutical medicine encompasses the entire area of discovery, research and development of medicinal products, their regulatory approval and benefit assessment as well as medical care in practical application.

For more information about DGPharMed, visit: www.dgpharmed.de.

EFSPI - European Federation of Statisticians in the Pharmaceutical Industry

EFSPI, the European Federation of Statisticians in the Pharmaceutical Industry, is open to constituted groups of statisticians. Eligibility for membership is open to one national group per country placing a major emphasis on technical and scientific activities directed at statisticians who are working in or for the pharmaceutical industry. Thus, EFSPI is engaged in statistical aspects of research, development, production, and surveillance of drugs and medical devices. The constitutional objectives of the Federation are:

• To promote professional standards of statistics and the standing of the statistical profession in matters pertinent to the European pharmaceutical industry.
• To offer a collective expert input on statistical matters to national and international authorities and organisations.
• To exchange information on and harmonise attitudes to the practice of statistics in the European pharmaceutical industry and within the member groups.

Volker Schoder, Director Biostatistics at METRONOMIA, is also part of the Estimands Implementation Working Group (EIWG) of the EFSPI.

For more information about the EFSPI, visit: www.efspi.org

EMWA - European Medical Writers Association

EMWA is the European Medical Writers Association, a network of professionals representing, supporting, and training medical communicators. It is a not-for-profit organisation run for its members by its members.

For more information about the EMWA, visit: www.emwa.org.

GMDS - Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V.

The GMDS

• is an independent scientific medical society,
• has its primary field of activity in medical informatics, medical biometry and epidemiology, including medical documentation in the healthcare sector in theory and application, in research and teaching,
• offers its medical informatics, biometric and epidemiological methods as a “cross-sectional subject” to all medical sub-disciplines in cooperation and develops these methods further, in particular with computer science, mathematics, statistics, economics, clinical research, bioinformatics and health services research,
• with currently around 2,000 members, is the only scientific society that represents these four disciplines together in Germany,
• cooperates with a number of neighboring specialist societies in exchanging experiences, pursuing common goals and organizing joint workshops, conferences or conference sections,
• further develops the representation of the disciplines through expert representation, e.g. in the planning of public funding measures, in questions of standardization and standardization, through statements, in the establishment of teaching institutions, in training, further and advanced training questions and in legislative measures.

For more information about the GMDS, visit: www.gmds.de.

IBS, International Biometrics Society

The International Biometric Society is an international society promoting the development and application of statistical and mathematical theory and methods in the biosciences, including agriculture, biomedical science and public health, ecology, environmental sciences, forestry, and allied disciplines. The Society welcomes as members statisticians, mathematicians, biological scientists, and others devoted to interdisciplinary efforts in advancing the collection and interpretation of information in the biosciences. The Society publishes two journals, Biometrics, reporting communications consistent with the Society’s mission, and, jointly with the American Statistical Association (ASA), the Journal of Agricultural, Biological, and Environmental Statistics (JABES). The Society is organized into geographically-defined Regions, each with at least 10 members. The Society is governed by an Executive Committee of General Officers and a legislative Council representing the international diversity of the membership. Regions elect their own officers and governing boards.

METRONOMIA is also part of the APF (Arbeitsgruppe Pharmazeutische Forschung) under the roof of the IBS-DR (Deutsche Region der Internationalen Biometrischen Gesellschaft, www.biometrische-gesellschaft.de).

This group aims to

• establish contacts between biometricians working in pharmaceutical research and development
• accelerate the exchange of methods between colleagues and develop new methods where necessary
• give mutual information on official regulations, methodological developments and scientific events

For more information about the IBS, visit: www.biometricsociety.org

PSI, Statisticians in the Pharmaceutical Industry

The PSI is a community dedicated to leading and promoting the use of statistics within the healthcare industry for the benefit of patients.

Founded in 1977 for pharmaceutical statisticians, members now span statisticians and other quantitative scientists with an interest in statistics working in all areas of drug development and healthcare, including research, pre-clinical, production, quality control, health technology, marketing, market research, academic statisticians and consultants.

PSI collaborates with similar organisations around the world, to advance healthcare by being a leading partner in the application of statistics. Together with other European statistical organisations, PSI is a member of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI).

As a non-profit organisation run by and for members, PSI supports its members throughout their careers, from education through to retirement. The community continues to grow and evolve in order to lead and promote statistical thinking within all areas of the industry. There are over 1000 members and more than 2000 people in our online communities.

PSI delivers relevant, up to date and leading support and resources including scientific meetings, online training, networking events, specialist working groups, training courses, career development, plus our renowned journal Pharmaceutical Statistics and our highly regarded annual conference.

Our activities inspire anyone interested in statistics working in healthcare to connect, learn and personally advance – so that everyone feels empowered to continue to serve the needs of this ever-changing and stimulating industry for the benefit of patients. Our hardworking and dedicated community of volunteers plans and delivers all PSI events by giving up their time to building PSI events of high quality.

For more information about PSI, visit: www.psiweb.org.

DIN EN ISO / IEC 27001

METRONOMIA's Information Security Management System (ISMS) is ISO 27001 certified. View certificate here.

For more information about GUTcert, visit: www.gut-cert.de/de/leistungen/informationssicherheit.