Clinical Oversight Management (COM)
Clinical Trials Supported
Participating Patients
Satisfied Clients
How ABRS leads innovation in medical device testing services
ABRS supports you at every step in clinical research, offering comprehensive services from initial human trials to post-market surveillance. We provide critical insights, unwavering support, and industry best practices, ensuring your clinical trials are not only successful but also conducted with confidence. At ABRS, we’re committed to partnering with you to achieve excellence in clinical research, adhering to FDA and GCP guidelines for the highest ethical and operational standards.
Clinical Oversight Management (COM)
Clinical oversight is crucial for identifying, assessing, controlling, and preventing risks in clinical trials.
ABRS is committed to implementing a robust Clinical Oversight Management (COM) program that aligns with ICH E6 standards.
Key Features of Clinical Oversight Management (COM):
1. Seamless Coordination:
• Our service streamlines the coordination of various aspects of clinical trials, ensuring a smooth and efficient process from initiation to completion.
2. Risk Mitigation:
• We prioritize risk identification and mitigation strategies, helping you anticipate and address potential challenges before they impact the progress of your clinical trial.
3. Strategic Oversight:
• Our experienced team provides strategic oversight, aligning every aspect of the trial with your overarching goals. This includes protocol adherence, regulatory compliance, and proactive issue resolution.
4. Expert Guidance:
• Benefit from the guidance of experts in the field who bring a wealth of experience to enhance the decision-making process and overall trial management strategy.
5. Effortless Navigation:
• Navigate the complexities of clinical trial management effortlessly, thanks to our proactive approach, attention to detail, and commitment to ensuring a well-coordinated and successful trial.
6. Optimal Outcomes:
• Our focus is on achieving optimal outcomes for your clinical endeavors. By leveraging our Clinical Oversight Management service, you enhance the likelihood of meeting study objectives and timelines.
7. Comprehensive Support:
• Enjoy comprehensive support at every stage, from study design and site selection to monitoring, data management, and regulatory submissions.
Whether you are a pharmaceutical company, a biotech firm, or an academic institution, our Clinical Oversight Management service is tailored to meet your specific needs. Trust us to be your strategic partner in ensuring the success of your clinical trials.
Benefits
- Tailored strategies for comprehensive safety at every phase of the trial
- Rigorous on-site evaluations to uphold participant well-being
- Thorough review of Informed Consent Forms to ensure clarity and compliance
- Meticulous review of participant data for integrity and accuracy
- Reconciliation between Investigator Site Files and Trial Master Files, whether electronic or paper-based, to maintain consistency
- Generation of detailed reports to pinpoint improvement opportunities and plan corrective measures
- Proactive approaches to track and rectify any protocol deviations
- In-depth examination of Investigator Site Files and electronic Investigator Site Files for compliance
- Critical analysis of laboratory records to verify precision and reliability
- Review of pharmacy and Investigational Product documentation to ensure proper management and record-keeping
FAQ's
ABRS offers a comprehensive range of services, spanning from study start-up to close-out, covering various phases of clinical research. This includes support for first-in-human trials, dose-ranging studies and pivotal trials.
ABRS provides critical insight, support, and best practices to ensure the success of clinical trials. Our commitment is to offer solutions that empower you to innovate with confidence, seize opportunities, and propel your clinical trials forward.
ABRS distinguishes itself by offering a broad spectrum of services that covers the entire clinical research process. We go beyond traditional support, providing not just services but also critical insights to help our clients navigate challenges and make informed decisions.
ABRS is dedicated to facilitating innovation in clinical research. We not only provide support for various phases of research but also aim to enhance opportunities for our clients. Our goal is to drive clinical trials forward by ensuring that our clients can navigate the complexities of the process with confidence.
ABRS has extensive experience in conducting clinical research in fourteen countries. Our global reach allows us to navigate diverse regulatory environments, ensuring seamless and compliant clinical trials.
ABRS boasts a highly skilled and experienced professional team dedicated to clinical research excellence. Our team members bring diverse backgrounds and expertise, collectively contributing to successful outcomes across various phases of clinical trials. With years of experience, they navigate complexities, providing clients with the confidence to overcome challenges in the ever-evolving landscape of clinical research.
Our Location
At ABRS, we currently provide coverage in
North America
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Latin America
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Europe
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Asia-pacific
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