Regulatory Affairs
Whether it’s a clinical trial or a medicinal product – we cover all areas for approval.
Clinical Research
Generation and compilation of clinical data through Clinical Trials compliant to GCP-standards.
We are proud to be listed in the BIOCOM directory and work closely with the Research Association of Drug Manufacturers (FAH) and the Institute of Clinical Research.
Mediconomics takes over your clinical project entirely or in parts. For instance: application, project management, monitoring, statistics and preparation of the final report.
Data Management
From capture to analysis – we ensure your data are of the highest quality, reliable and trustworthy.
Our services include:
- eCRF design and preparation of annotated CRF
- Database design, programming of data entry screens and edit checks
- EDC and double data entry
- Transfer and integration of external data (e.g. laboratory)
- Coding (Adverse Events, diagnosis and concomitant medication)
- Data validation and query management
- Quality control and database lock
- (Blind) Data Review
- SAE reconciliation
- Setup of status reports and statistics
- Preparation of statistical or integrated final reports
Regulatory Affairs
Whether it’s a clinical trial or a medicinal product – we cover all areas for approval.
Our regulatory operations are grouped into Clinical Trial Regulatory Affairs and Drug Regulatory Affairs:
Clinical Trial Regulatory Affairs:
- Regulatory consultancy and advice
- Approval, amendments, notifications and reporting
- Coordination and communications of/with competent authorities, ethics companies and local authorities
- Insurance handling
- Deadline monitoring
Drug Regulatory Affairs:
- Scientific and regulatory advice meetings
- Management and submission of eCTDs, nationally and internationally
- Preparation and conduct of authorisation procedures (CP/DCP/MRP/NP)
- Maintenance and life-cycle management of marketing authorisations (Variations, Renewals, etc.)
Product Development
Professional advice and scientific guidance at all stages – we manage your pharmaceutical development.
Medicinal products
We proudly provide all services for clinical trials (phase I-IV), project management, data management, medical writing and pharmacovigilance. Essential steps need to be addressed, including design performance and safety, business economics, risk management and regulatory requirements. With these considerations in focus, we adhere to the criteria in ISO 9001:2015, which address a system of quality management standards. You can delegate the complete project or parts of the development process, and we will generate an individual road map that fits your product and helps to circumnavigate delay causing pitfalls with such vital ventures.
Medical devices
The certification procedure for medical devices belongs to our day-to-day business. The process is becoming more and more demanding and faces increasing requirements for proving the suitability of a potential medical device. Nevertheless, innovations ought to be marketable in a commercially acceptable period of time. For you to remain competitive, Mediconomics’ sister company Medicoforum GmbH (certified acc. to DIN EN ISO 13485:2016) takes care of the correct classification, optimisation of the technical documentation and complete certification process.
Pharmacovigilance
Focussed on safety – we manage your drug safety obligations as a marketing authorisation holder.
Our services include:
- Evaluation of the current PV status
- Literature research
- Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
- Implementation of PV systems and alarm plans
- EU-conform electronic reporting (XEVPRM, ICSR),
- Compilation of Risk Management Plans (RMPs)
- Training, audit and more
Medical Writing
Precise and accurate – we develop and generate tailor-made documentation.
Our services include:
- Study designs and protocols
- IMPD
- IB
- Investigational Plans
- Integrated Study Reports
- Expert Reports (eCTDs)
- Biological Evaluation Reports /Clinical Evaluation Reports (CER/BER)
- Toxicological assessments
- Preparation of manuscripts for publications
Mediconomics Factsheet
Our focus:
Contract services for Clinical Research with Medicinal Products, Medical Devices and development candidates as both full and single-service.
Projects overall:
160+ Clinical Research Projects
40+ Patents
Competence status:
Certified acc. to DIN EN ISO 9001:2015, CTR 536/2014, German Medicinal Products Act, in-depth knowledge of GCP and GMP, patent law and up-to-date expertise.
You’re welcome.
Managing Director:
Dr. (MD) Uwe Albrecht,
FIBMS, MFPM (Dis.), MICR, CSci
Tel.: +49 (0) 511 560 998-0
Mediconomics GmbH
Misburger Straße 81 b
D-30625 Hannover
Germany
Organised in:
German Federal Association of CROs (BVMA)
German Society for Regulatory Affairs (DGRA)
European Medical Writers Association (EMWA)
Research Association of Drug Manufacturers (FAH)
Institute of Clinical Research
Society for Clinical Data Management (SCDM)
US BIOCOM directory
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