Expertise.

Good Clinical Practice (Clinical Trial).

Ensuring GCP compliance and data integrity through customized solutions for clinical trials.

Secure?

Do you ensure data integrity in your clinical trials through SDV and SDR?

Compliant?

Do your studies meet the regulatory requirements of the GCP and EU Regulation (EU) No. 536/2014?

Ready?

Are your test centers optimally prepared for GCP audits and inspections?

Optimize your clinical trials now.

Good Clinical Practice - Compliance and quality assurance for clinical trials.

Our GCP Consulting Services support you in ensuring compliance with GCP standards in your clinical trials and ensuring the quality of your studies.

We offer you comprehensive support in complying with international regulations, including Regulation (EU) No. 536/2014. Through regular audits of your test sites and data, we ensure that you always comply with Good Clinical Practice requirements and pass inspections with ease.

Our services include:

GCP compliance services at a glance.

Our GCP Consulting Services offer comprehensive support in ensuring compliance with international GCP standards, optimizing your clinical processes and assuring the quality of your clinical trials.

Regulatory compliance.

Risk management.

Data integrity & quality assurance.

Successful Good Clinical Practice compliance in clinical trials.

Our case studies show how Good Clinical Practice Consulting has helped companies to ensure compliance with GCP standards and successfully conduct clinical trials.

Challenge.

A medical technology company needed to manage risks in a clinical trial while shortening the study time.

Measures.

  • Implementation of a GCP-compliant risk management system.
  • Introduction of BRAT (Benefit-Risk Action Team) for risk assessment.
  • Adaptation of risk strategies to accelerate studies.

Results.

  • Reduction of study risks by 40%.
  • Acceleration of study time by 15%.
  • Improving the traceability of risks.

Success.

Successful implementation of a comprehensive risk management system and acceleration of studies.

Optimize your clinical trials with GCP Consulting.

Our GCP Consulting Service Portfolio.

Our Good Clinical Practice Consulting Service portfolio offers comprehensive support to ensure GCP compliance and optimization of your clinical trials. We support you in complying with global regulations and standards and ensure the highest data integrity and study quality.

Ensuring compliance with international GCP standards, including Regulation (EU) No. 536/2014 and ICH GCP guidelines.

  • EU Clinical Trials Regulation (EU) No. 536/2014: Support for the implementation of the regulation, which guarantees shorter approval times and the simplification of multinational clinical trials in the EU
  • Global GCP standards: We ensure compliance with ICH GCP guidelines, which set globally harmonized standards for clinical trials to ensure consistent data quality and patient safety

Preparation for GCP audits by the EMA and inspection readiness according to international regulations.

  • EMA GCP inspections: Helping to prepare for GCP inspections by the European Medicines Agency (EMA) and ensuring that all sites are brought up to date
  • Inspection procedures: Implementation of a robust audit system for GCP compliance and preparation for regulatory inspections according to Regulation (EU) No. 536/2014

Ensuring the data integrity and quality assurance of your clinical trials through SDV and SDR.

  • Source Data Verification (SDV) and Review (SDR): Conduct comprehensive data reviews to ensure that all clinical data is accurate and complete.
  • Quality assurance audits: Implementation of QA audits to ensure compliance with GCP standards in all clinical processes and to identify and address potential risks at an early stage.

Introduction of GCP-compliant risk management strategies to proactively control potential risks in clinical trials.

  • Risk management according to GCP: Identification and control of risks that may affect patient safety or data quality through the implementation of a comprehensive risk management system
  • Proactive risk control: Regular evaluation and adjustment of risk strategies to minimize violations and ensure compliance with all regulatory requirements.

Ensure comprehensive GCP compliance with Entourage Consulting.

Related topics for compliance with Good Clinical Practice in studies.

These supplementary services support you in planning, conducting and monitoring clinical trials in accordance with GCP guidelines:
Medical Writing
Creation of precise, compliant and well-structured documentation for the pharmaceutical, biotech and medical technology, ...
Clinical Project Management
Efficient planning, implementation and follow-up of your clinical trials in the life science industry.
Inspection Readiness
Ensure that your products and processes comply with regulatory requirements.
Clinical Monitoring
Ensure compliance with GCP standards and data integrity in your clinical trials.