Monitoring of clinical data
Monitoring of clinical data
Thorough Medical Oversight: The Only Road to Safety
From protocol development and study design through to study close-out, medical oversight of all stages and activities of your clinical trial is of prime importance to meet your objectives while ensuring the integrity of your data. You are likely to require assistance in order to:
- Provide input into clinical development plans, protocol designs and risk assessments
- Train and support investigational sites on potential subject safety issues, subject rights and medical emergencies
- Review and enhance the quality of study deliverables
- Verify the consistency and accountability of your data
- Process SAEs, manage medical coding and write safety narratives
Prepare for or participate in DSMB meetings
Compliance, Compliance and More Compliance to Mitigate Risk
We are highly conscious of the importance of demonstrating your commitment to patient safety to regulatory authorities. In order to demonstrate the therapeutic potential of your product, you require fully compliant and high-quality bespoke vigilance and safety solutions that enable you to comply with the strictest regulatory requirements, manage the benefit-risk profile of your product and ensure patient safety.
Dedicated Clinical Research Associates (CRAs)
Our in-house team of CRAs receives continuous training to ensure they remain knowledgeable and up to date with the latest techniques, technologies and regulatory developments. A Lead CRA dedicated to your study directs a team of field-based CRAs and oversees all monitoring activities carried out at participating investigational sites.
Risk-Based Monitoring Plan
We carefully design a risk-based monitoring plan, which serves as the framework for all monitoring activities. We focus on detecting, mitigating and preventing errors that may create risk, improving patient safety and enhancing the reliability of your clinical data. A patient-centric and proactive early-detection approach minimises risk and enables effective and efficient solutions.
Remote Monitoring
When appropriate, we utilise virtual monitoring technology, allowing CRAs to perform monitoring activities remotely and reducing the significant costs and downtime associated with travel.
Stay Ahead of Vigilance Regulatory Requirements and Avoid Unnecessary Costs and Delays
Strict compliance with vigilance procedures and ICH Good Clinical Practice requirements helps minimise unnecessary costs and delays. Our team of vigilance specialists, comprising physicians, pharmacists and life sciences professionals, works closely with sponsors, investigators and regulatory authorities to effectively monitor, assess and report safety data in a timely and compliant manner.
Our capabilities include:
- Vigilance consulting
- EU QPPV and Local QPPV activities
- Pharmacovigilance System Master File (PSMF)
- Safety Data Exchange Agreements (SDEAs)
- Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
- SAE and SUSAR monitoring, reporting and follow-up 24/7
- SOP development and support
- Vigilance training
- Safety database management (set-up, maintenance, etc.)
- Preparation for audits and inspections
- CAPA management
- EudraVigilance
- Benefit-risk assessment
Our laboratory
1, rue des Essarts, 38610 Gières, France
Supporting your clinical trials
Looking for a trusted partner to support your clinical trials? Let’s discuss how we can support your development programme.
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