Clinical Operations

Trial Management

Trial document operational review

Developing phase appropriate plans and manuals when planning a clinical trial is essential to ensure comprehensive and effective management of every aspect of the study. These plans and manuals collectively guarantee that the trial is conducted efficiently, ethically, and in compliance with all necessary guidelines and regulations.

We can support your clinical teams in developing trial specific plans or review the existing ones, ensuring seamless and compliant clinical trial operations in line with your organization’s processes.

Trial specific risk management

Risk management in clinical research has increasingly become an expectation from regulators. ICH-GCP requires Sponsors to implement risk-based approaches during the lifecycle of the clinical trials.

Our risk management consultancy services are designed to help you proactively manage trial specific risks. We work closely with your teams to conduct thorough risk assessments, develop the optimal risk management strategy, and implement effective mitigation plans.

Risk control strategies

Accept

Acknowledging and accepting the risk when it is unlikely to occur, the impact is minimal or when the efforts outweight the benefits

Transfer

Shifting the risk to another party, e.g. by outsourcing (operational risks) or insuring (financial risks)

Avoid

Eliminating activities or processes that pose unacceptable risks removing the chance of them becoming an issue

Mitigate

Implementing measures to reduce the likelihood or impact of the risk

eTMF QC

The Trial Master File (TMF) serves as the central repository for all essential documents and allows to re-construct the clinical trial, helping demonstrate compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. This is crucial for the integrity and credibility of the clinical trial results.

We offer tailored quality checks (QC) for your electronic Trial Master Files (eTMFs). Our services can be adapted to meet your specific requirements, and can include detailed inventory checks or risk-based assessments.

CRA Assessment and Mentoring

Training and Qualification of the Clinical Research Associates (CRAs) are critical requirements under ICH-GCP. The aim is to guarantee efficient monitoring visits that meet their purpose:

Ensuring the protection of the rights, safety and well-being of human subjects

Ensuring the reliability of the trial results based on accurate, complete and verifiable data

Ensuring the compliance with the approved protocol, GCP and applicable regulatory requirements

Through our accompanied visits with your CRAs, we evaluate their competencies, skills, and knowledge and can provide on-the-job training, guidance and support by sharing knowledge and expertise.