Clinical Operations Network
Amselstra├če 25
D-68307 Mannheim, Germany
(nearest airport is Frankfurt/Main)
Tel.: +49 (621) 789 7000
Fax: +49 (621) 789 7010

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Clinical Monitoring

Well educated and reliable CRAs play a major role in the successful conduct of a study. CONET's CRA team is highly qualified, experienced and will expertly monitor protocol compliance and data integrity.

The basis of CONET's high quality performance is:
  • Continuous Training
    Training is performed on a regular basis by our quality assurance team or external trainers and is supported by our experienced project managers and Lead CRAs.

    CONET professionals are currently and extensively trained on protocol, ICH/GCP guidelines, CONET's own and relevant client SOPs, and the monitoring plan. Our CRAs operate in full compliance with international and local regulations, as well as with ethical and scientific standards. They work closely with the project and data management teams to be proactive regarding patient safety, investigational medical product (IMP), central lab management and particular site issues, including appropriate CRF completion. Additionally the assigned Lead CRA gives practical guidance throughout the study.

    As our CRAs are always in close cooperation with the sites, compliance with study protocol and regulatory requirements is ensured as well as proactive problem solving and finding rapid and effective solutions. Patient rights and their well-being are always protected.
  • Quality Control
    Internal quality control checks are established in order to ensure compliance with SOPs and other quality management tools. Additionally co-monitoring visits with all CONET CRAs as well as all CRAs from our partner CROs are routinely performed by the project managers or our highly experienced Lead CRAs.

    Co-monitoring, as one of our quality control tools, is to ensure consistency of performance throughout the CRA team and at all participating study sites. With these activities, problems or errors due to the complexity of the study are detected at a very early stage. As a result, re-training of the CRA team and the site staff can be performed in order to meet the study requirements.
  • Networking
    Our full-service CRO is named CONET which means Clinical Operation Network. For more than a decade we have developed a stable network of business relationships with our partner CROs. Depending on the project we will involve experienced CRAs from our partners in Western and Eastern Europe in addition to the CONET staff in Germany and Russia.

    Within our reliable and sustainable network we are able to conduct large multi-center trials in Western and Eastern Europe with the advantage of performing monitoring activities in all countries by regionally located, multi-lingual CRAs (English + local language) with local expertise.

    Our client's benefits from contacting only one assigned project manager, located at our headquarters in Mannheim, Germany, who is responsible for managing the entire study monitoring team. While we are expanding our network from Europe to the USA, Israel and India, the central point of contact will remain the project manager in Mannheim for our clients. Please feel free to contact us anytime for more information on how we can be your exceptional European monitoring team.
CONET's CRA team will assist you with the following clinical monitoring activities:
  • Site selection, initiation, and routine monitoring including, source data verification, site file review and drug accountability management
  • Review of authenticity and eligibility of subjects
  • Site personnel qualification, continuous training and investigator oversight
  • Regulatory and essential document collection
  • In-house monitoring
  • Rescue monitoring
  • Site inspection preparation
  • Status overview and subject recruitment
  • Query management and site support in problem solving
  • Site close-out activities

The clinical monitoring team always meets the highest standards and requirements of our clients due to the seamless interaction between the team members and their proactive thinking and fast, accurate execution.

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