STEADILY WORKING ON THE FUTURE OF HEALTH
Medicinal Products & Medical Devices Clinical Research & Phase I–IV Trials Data Management & eCRF Design Regulatory Affairs & eCTD Management Product Development & Consulting Pharmacovigilance & Risk Management Medical Writing & Expert Reports

Mediconomics provides spot‑on professional CRO services.

Mediconomics is a successful CRO and consultant for research and development projects of both Medicinal Products and Medical Devices.

Headquartered in Hannover, Germany and with subsidiaries in Denmark, Switzerland, the UK and US, Mediconomics operates within an international network. It goes without saying that all activities are compliant with the relevant guidelines in the consistently-changing regulatory environment.

With Quality Management being one of our foundations of success, all members our interdisciplinary team are not only trained continuously to the latest standards, but we also maintain a certified Quality Management System acc. to DIN EN ISO 9001:2015

The core philosophy, derived from more than 20 years in successful client relationships, is to keep the company small enough to provide flexible, bespoke solutions but large enough to deal with complex situations.

Since 1999, our systematic and tailor-made approach has earned us an excellent reputation, and we would be proud to be part of one of your projects.

Our services – best practices for your Clinical Research and Product-Development projects

We use our skills and extensive experience for the development of ambitious solutions for your projects. We employ a systematic and tailor-made approach and understand that the faster the outcome of the projects, the greater would be your advantage in the market.

Organised in six different categories, we provide our services either as full-service or just parts of our portfolio. Whenever you require it, we are more than happy to serve you with our expertise in both the conduct and as a consultancy service.

For a comprehensive yet clear overview, further information is available by opening each of the categories below.

Clinical Research

Generation and compilation of clinical data through Clinical Trials compliant to GCP-standards.

For numerous diseases, there is no satisfactory therapy available. Medicinal products, as well as medical devices, are tested in clinical trials with regard to their (pharmaceutical) quality, efficacy and safety. Pharmacoeconomic evaluation becomes more relevant at this stage, as also in addition to the medical aspects the cost-benefit analysis of an innovation is of paramount importance. We have a strong record in the coordination of Phase I-IV clinical trials in a wide range of therapeutic areas. Our multinational team assists you throughout trial design and conduct, ensuring the highest quality data are obtained. Furthermore, we are specialists in the supervision of essential post-marketing studies, including PASS and NIS.

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.

During a clinical trial, a lot of information is gathered and needs to be structured to allow for precise, scientifically sound analysis. Using state-of-the-art software and online-technologies, we reach the inherent goal of Data Management: Data Quality. Based on our experience and field-tested procedures, as well as our involvement as a member of the Society of Clinical Data Management (SCDM), we safeguard rapid and secure handling of the sensitive data.

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.

All phases in pharmaceutical development are governed by strict regulatory hurdles to ensure the efficacy and safety of pharmaceutical products. At Mediconomics, we are well experienced with the many peculiarities and have reached approval in a wide range of procedures. In addition, we are actively involved in promoting education and training in this field and are registered with the German Society for Regulatory Affairs (DGRA).

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

At Mediconomics, you will be guaranteed of appropriate advice and support towards the development of your drug candidate, after successful completion of the preclinical phase.

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.

Pharmacovigilance (PV) legislation was formalised and implemented by the EU in 2012 in order to regulate the detection, management and prevention of adverse reactions to medicines in patients. In line with these changes and to fulfil and implement the obligations of Pharmacovigilance, organisations authorised to produce a medicinal product for human use now require the services of a Qualified Person responsible for Pharmacovigilance (QPPV). Mediconomics have the expertise and approval of the European Medicines Agency (EMA) to provide your organisation with tailor-made Pharmacovigilance solutions, saving you valuable time and expense.

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.

Precision and accuracy define medical writing at Mediconomics. Science-based documents need to be accurate and easily legible. Our experienced medical writers have an eye for detail and accuracy. They are members of the European Medical Writers Association (EMWA) which supports their continuous professional development, ensuring your documents are delivered to the highest scientific and ethical standards.The results are clear and structured documents which supersede questions and explanations, thus saving valuable time during the phase of validation and evaluation. Based on the firm foundation of many successful projects, we can provide expert advice for your medical writing requirements in the fields of regulatory affairs, clinical research and PV.

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

Events – Looking forward to meet you soon

Nowadays, it has become a fashion to communicate online, and personal meetings are less frequent. At Mediconomics, we believe that, as human beings, we rely on personal interactions as an integral part of building a partnership and trust. Perhaps we could meet at one of the following conferences and learn more about you and the needs of your projects:

BIO-Europe 2020

Virtual Event

26.10.2020 – 28.10.2020

Outscourcing in Clinical Trials

Virtual Event

02.11.2020 – 04.11.2020

28th BVMA Symposium

Munich, Germany

27.11.2020

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

contact@mediconomics.com

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

STEADILY WORKING ON THE FUTURE OF HEALTH
Medicinal Products & Medical Devices Clinical Research & Phase I–IV Trials Data Management & eCRF Design Regulatory Affairs & eCTD Management Product Development & Consulting Pharmacovigilance & Risk Management Medical Writing & Expert Reports

Mediconomics provides spot‑on professional CRO services.

Our services – best practices for your Clinical Research and Product-Development projects

Clinical Research

Generation and compilation of clinical data through Clinical Trials compliant to GCP-standards.

Data Management

From capture to analysis – we ensure your data are of the highest quality, reliable and trustworthy.

Regulatory Affairs