Project manage­ment

As part of project management services, the CROCKID team assumes the following functions:

  • Preparation of project management plans: project management, monitoring plan, data and risk management plan
  • Submission of documents to regulatory authorities for obtaining permission to conduct research
  • Selection and opening of clinical centers throughout the Russian Federation, the EAEU and CIS countries
  • Formation of a qualified research team, trainings on research documents
  • Interaction with local ethics committees of organizations to approve all research documents
  • Coordination and signing of contracts with clinical centers
  • Organization of procurement of research materials
  • Work with analytical laboratories
  • Monitoring compliance with project deadlines and budget
  • Selection of any suppliers for the project implementation

  1. Selection and evaluation of clinical centers

  2. Submission of documents to regulatory authorities for obtaining a permit for carrying-out a clinical trial

  3. Interaction with the local ethics committees with the aim of approval of all documents of a trial

  4. Preparation of project plans: project management, monitoring, statistical plans, data and risk management plans

  5. Approval and signing of contracts with clinical centers

  6. Organization of materials for a clinical trial purchasing

  7. Cooperation with bio-analytical laboratories

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ClinPharmDevelopment

Is an independent contract research organization successfully implementing preparation for and carrying out of clinical trials of all phases within the territory of Russia and EAEU countries.

We employ more than 30 people, including 6 PhD degree holders. All employees involved in trials have a university degree in medicine or pharmacy, GCP/GLP certificates, and broad experience of participating in clinical trials.

The company successfully cooperates with the centers of the Russian Federation for preclinical research that meet all modern requirements, localized in Moscow, St. Petersburg, Yaroslavl."

Own highly specialized licensed software that meets E2B ICH standards and regulatory requirements of the Russian Federation, EAEU and CIS
Compliant with E2B ICH standards and regulatory requirements of the Russian Federation, the EAEU and the CIS
Fruitful cooperation with Roszdravnadzor in the field of drug safety monitoring
Performing the function of collecting and processing spontaneous messages
An effective document management system
Completeness, accuracy, data integrity, an organized set of measures to ensure the security of information storage and its confidentiality
2,000+ analyzed cases of adverse reactions
Formed own database of 300+ drugs
Timely informing the customer and regulators

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