A small German CRO based in Memmingen (Allgäu), founded in 2015, with focus on CRO Oversight, Project Management, Monitoring & more.
More than 25 years of CRO experience, paired with experience in the industry, guarantee professional CRO oversight and customer-oriented project management on behalf of sponsors.
Our expertise ranges from clinical studies to non-interventional trials in the field of Medicines and Medical Devices.
Individual support and concepts, tailored to the customer’s need
Uncomplicated and adaptable
Working with quality and knowledge within the framework of the requirements
In business since the introduction of the ICH-GCP rules and still fresh
The service does not end at the edge of the box
A good team- a happy site
We support and advise you in all phases of project execution - from planning, set-up and implementation, to reporting.
With the involvement of external partners for pharmacovigilance, data management and biometry, we are the right CRO for you to carry out complex projects / studies.
CRO selection, contract processing, budget control, supervision of operational processes, risk management, SOP handling, project plans & more
Planning and management of studies, risk management, budget control and timeline monitoring, interface and third-party management & more
On-site and remote monitoring, site management, training of the investigational sites & more
Submissions to the responsible ethics committees and authorities, fulfillment of the reporting requirements during the study, registration of the study & more
Carrying out audits, co-monitoring, preparation / consultation of sites for planned inspections by authorities & more
Advice and support in the development and revision of SOPs & more
Master of Biology with additional training in Quality Management, 25 years of CRO and industrial experience.
Activities as a CRA, project manager, line manager for CTAs and PMs, CRO oversight manager, medical manager - also performing quality management-relevant functions (development of SOPs, co-monitoring, quality control, inspection management) and regulatory processes (submissions).
In the Clinical Research Business since completing her biology studies in the year2000. CRO Oversight and Project Management learned from scratch: in the classic way from CRA to global project manager, direct involvement in all operational areas.
Experience in a wide variety of projects, phases and indications in the fields of regulatory affairs, monitoring, project management, vendor management, TMF management, data review, and SOP creation, is the result of 15 years working for a medium-sized CRO and made the foundation of CLINVICES in2015 possible.
Clinical research professionals with extensive knowledge and experience in project management / assistance, monitoring, quality assurance and medical writing.
From a network of experienced freelancers in the field of project management, monitoring and medical writing, an optimal team is put together that is adapted to the project needs.
COOPERATION WITH medACT
Full service projects are standardly performed in cooperation with the CRO medACT-Analysis of Clinical Trials – a company of the Steinbeis group - taking care of data management and biometrical services.
www.medact.de
Our employees are evenly distributed across Germany - from here, our team also covers projects in Switzerland and Austria.
Cooperation with freelancers and CROs abroad are available for the implementation of multinational projects.