ICS – in.vent Clinical Services

ICS is the newest expansion of our service portfolio. We have harnessed our 20 years of expertise in diagnostic studies to conceive a new level of IVD-services: A complete all-round package covering every step of diagnostic assay validation, including all performance studies, study protocols, and reports.

Place your trust in our expertise: We know which and how many samples will be required for the validation of your assay. We will perform, manage, and document the analytical and clinical validation in an IVDR-compliant manner. We will get your assay CE-certified.

ICS was founded with regard to the major challenges for the European diagnostics industry that arise with the implementation of the EU regulation 2017/746 on in vitro diagnostic medical devices (IVDR 2017/746). It is our goal to help global IVD developers and manufacturers to master this challenge.

Closeup portrait, scientist pipetting from 50 mL conical tube with blue liquid solution, performing laboratory experiments, isolated lab . Forensics, genetics, microbiology, biochemistry
Business people working together in meeting room
group of medical workers portrait in hospital

Therefore, we offer a one-stop service covering every relevant step of the IVD validation and marketing process:

  • Performance Evaluation Plan
  • Sample Procurement & Processing   
    • Communication with Ethics Committee & Legal Authorities   
    • Study Site Initiation & Monitoring   
    • Informed Consent
  • Study Protocols
  • Analytical Performance Studies
  • Clinical Performance Studies
  • Data Management 
  • Biostatistics
  • Performance Evaluation Report
  • CE-Marking
  • Post-Market Surveillance

Homepage

www.ics.bio

Contact

ics@inventdiagnostica.de

Location

Neuendorfstraße 17
D-16761 Hennigsdorf bei Berlin

Main office: +49 (0) 3302 55199-0
FAX: +49 (0) 3302 55199-999

E-mail: info@inventdiagnostica.de

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© 2019

ES IST EIN INNOVATIONSASSISTENT ÜBER DEN EUROPÄISCHEN SOZIALFOND FÜR DEN AUFBAU FOLGENDER INNOVATION BESCHÄFTIGT:

  • Die betriebliche Innovation soll zur Entwicklung von neuartigen Produkten, Standardmaterialien und Standard-Services (PMS) für den proaktiven Vertrieb am diagnostischen Weltmarkt führen. Produkte und Standardmaterialien werden in die firmeneigene Website und das interne digitale Projektmanagement-Betriebssystem (CRM) implementiert“
  • Ziel ist es, die Entwicklung und Etablierung dieser Produkte und die Etablierung dieses Prozesses im Allgemeinen innerhalb von zwei Jahren abzuschließen. Der Prozess muss dynamisch reproduzierbar sein. Bestehende PMS bedürfen des regelmäßigen Monitorings.
Qualification measures:

Growing Organisation; Adaption of Qualification to new market demands, project areas and fields of production

To achieve the goal, that invent persist at the international market, qualification for current and new employees were conducted as follows:

  • training in online-marketing,
  • in contract law and
  • in business basics for executive leadership with scientific background.

New employees acquired competences in the fields of:

  • data protection,
  • medical devices advice,
  • internal auditing,
  • performance assessment of in-vitro diagnostics as well as
  • project management

In the field of production, knowledge of macro programming was gained for digitization.

The measures were funded through the European Social Fund and the state of Brandenburg for the period 2019 – 2021.