Support in line with the ICH Efficacy Guidelines
GRA provides support for Clinical Development and Monitoring activities in line with the ICH Efficacy guidelines.
We also provide Clinical Project Management services to coordinate the clinical development activities and perform clinical monitoring to ensure that trials progress smoothly, ethically and effectively.
Leveraging our expertise helps organisations navigate the complexities of clinical development and monitoring, ultimately accelerating and maximising the likelihood of successful clinical trials and regulatory approval. This robust approach feeds quality data into any potential machine learning to drive an AI assisted Quality by Prediction approach.
Clinical Endpoints
Definition, selection and analysis of 1º and 2º endpoints. This ensures endpoints are clinically meaningful, measurable and statistically valid. They must align with regulatory expectations with data capture across sites and patient populations.
Powered Trials
Trial design is grounded in statistical power calculations to detect meaningful differences. This involves population selection, sample size determination, randomisation strategy and minimising bias to reach clinical conclusions.
Clinical Trials I, II & III
Design, initiation and oversight of clinical studies, progressing from early safety evaluation to large-scale efficacy testing. This includes clinical protocol development, briefing booklets, regulatory submissions, ethics approval, patient recruitment, dosing, monitoring and endpoint analysis.
Efficacy & Safety
Assessment of therapeutic benefit and risk through predefined endpoints while monitoring for adverse events. This includes safety reporting, Data Safety and Monitoring Board (DSMB) coordination and integration of clinical findings to support decision-making at each development stage.
Site Management and Monitoring
Engagement, training and oversight of clinical sites ensures protocol adherence, data accuracy and patient safety. This includes source data verification, compliance checks, query resolution and real-time monitoring to maintain study quality and integrity.
Frequently Asked Questions
ICH Good Clinical Practice (GCP) is set out in ICH E6(R3) and provides a common international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. The fundamentals—informed consent, independent ethical review, investigator/sponsor oversight, protocol compliance, safety reporting, and data integrity—are broadly aligned across the UK, EU, and US.
The practical execution differs primarily by regional administrative procedures:
- United Kingdom (MHRA): Principles are implemented through the UK Clinical Trials Regulations and supported by MHRA guidance. Clinical trials of Investigational Medicinal Products (IMPs) require regulatory authorisation from the MHRA and positive ethics approval.
- European Union (EMA): Operates under the EU Clinical Trials Regulation (CTR). Trial applications, ethics reviews, scientific assessments, and communications across Member States are managed centrally via the Clinical Trials Information System (CTIS) portal.
- United States (FDA): Adopted alongside applicable 21 CFR regulations. Clinical trials require an Investigational New Drug (IND) application and Institutional Review Board (IRB) approval. An IND takes effect 30 days after receipt by the FDA unless placed on clinical hold.
In summary, a trial across the UK, EU, or US can use a largely common protocol, quality-management system, and GCP framework with no fundamental scientific differences between agency approaches. The practical differences are procedural and administrative rather than scientific.