The MedSurv portal

Who we are

With the MedSurv portal, we provide our customers with an online EDC system for data collection in

  • Clinical studies
  • Non-interventional studies (NIS)
  • Patient registry
  • Post-marketing observational studies
  • PMCF studies

How we work

We assist our customers all along their way - from their planning of the eCRF to the validation of the system. We also ensure that all project steps are undertaken in a well-structured sequence.

On request, we can offer a full service with reliable and internationally active partners, such as CROs, data managers, statisticians, biometrists, etc.

What makes us who we are

We offer our costumers

  • Strong project management
  • Fast response times
  • Sustainability
  • Direct and personal support

Our quality results from our certified management system. We are constantly developing ourselves and our user-friendly tools further.

Compliance

MedSurv is validated according to GAMP5 and certified according to ISO 9001. From these two processes, a well-functioning integrated management system has emerged, which has already successfully passed several audits. Our approach is based on the following guidelines and standards:

  • EU Guidelines on GxP, Annex 11 "Computer-Assisted Systems"
  • US FDA 21 CFR Part 11 - Electronic records, electronic signature
  • FDA Industry Guidelines - Computer-assisted system within the framework of clinical trials and studies
  • CDISC
  • ICH-GCP Guidelines
  • Internal SOPs as well as project-relevant SOPs of our customers

Modules

    • Tracking of changes according to legal requirements
    • Customisable algorithm
    • Reliable ratio
    • (Serious) adverse events are automatically processed
    • Virtual data check
    • Current patient and visit status
    • Management of the centres
    • Additional validation process according to DVP
    • Direct communication in the portal
    • Daily updates of study data
    • Transparency
    • Remuneration
    • Recruitment status...
    • Uploading of documents with patient allocation
    • Direct collection of questionnaires (QoL)
    • Patient diary

Testimonials

News

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Positive press release of Biofrontera AG

Our longtime customer Biofrontera AG from Leverkusen reports positive results of the phase III trial with Ameluz®. We are pleased to support Biofrontera in their study with our EDC system. The brand new press release, as well as the positive preliminary results on the primary endpoint were published at the following link: https://irpages2.eqs.com/websites/biofrontera/German/15/news-detail.html?newsID=1762013
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BIONNALE in Berlin!

BIONNALE is the largest networking event for life sciences and healthcare industries in Berlin. It covers current topics as the new regulatory requirements in medical technology, IT security in the field of digital health and many more. More information can be found here: https://bionnale-2019.b2match.io We look forward to meeting you at BIONNALE on 7 May 2019!
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Medtec Live 21.–23. May 2019

Visit us at the Medtec Live in the exhibition halls Nuremberg at booth 10.0-628. In the period from 21 to 23 May 2019, we are on site as an exhibitor. Make an appointment directly with our sales team. For more information look here: www.medteclive.com
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Career

MedSurv GmbH is still looking for additional staff. Please apply for one of the following vacancies or send in your speculative application.

Softwaredeveloper (m/f/o), Apprentices Computer Sciences (m/f/o), Interns and working students (m/f/o)

Please send your application documents to Tina Biehl (job@medsurv.de). We look forward to receiving them.