Clinical Safety & Compliance
"Where Patient Protection Meets Scientific Progress: Delivering End-to-End Clinical Safety and Regulatory Compliance Excellence"
SUSAR Management
“A Distinctive Approach.”
Suspected Unexpected Serious Adverse Reactions (SUSARs) are critical in clinical research, representing adverse events that are both serious and unexpected, and possibly related to the investigational drug. Effective management of SUSARs is essential for patient safety, regulatory compliance, and maintaining the integrity of clinical trials.
At CliniResource, we go beyond standard SUSAR management practices to deliver a seamless, proactive, and transparent experience. We leverage cutting-edge technology to monitor clinical trials in real-time, ensuring that SUSARs are identified and reported promptly. This not only meets regulatory requirements but also ensures quick action to safeguard patient safety. Our team has deep knowledge of international regulatory guidelines, including those from the MHRA, FDA, EMA, and other key agencies.
We tailor our SUSAR reporting strategies to meet regional compliance standards, reducing delays and avoiding costly errors. We empower your team with training sessions on SUSAR management best practices, fostering a culture of compliance and proactive safety measures. By choosing CliniResource, you gain a partner dedicated to enhancing patient safety and driving the success of your clinical trials. Contact us today to learn more about how our tailored SUSAR management solutions can make a difference in your research endeavors.
Medical adjudication of SAEs
“Standardized SAE Review by Global Experts”
Medical adjudication of Serious Adverse Events (SAEs) is a critical process in clinical trials, where an independent panel of experts evaluates and validates adverse event data to ensure accuracy, consistency, and compliance with regulatory standards.
This step ensures that trial outcomes are reliable and that patient safety remains a top priority. At CliniResource, we bring innovation, expertise, and a client-centric focus to the complex process of medical adjudication. We curate panels of highly qualified medical experts from major therapeutic areas, tailored to the specific therapeutic area of your clinical trial.
Our adjudicators are trained to evaluate SAEs with objectivity, ensuring decisions are evidence-based and aligned with regulatory guidelines. We understand the complexities of adjudicating SAEs across global trials. Our team is well- versed in the varying regulatory requirements of major health authorities, ensuring your data is compliant, no matter where the trial is conducted.
Partner with CliniResource for a smarter, more reliable approach to medical adjudication of SAEs. Let us help you ensure patient safety, maintain compliance, and achieve your research goals with confidence. Contact us today to learn more about our unique capabilities and how we can support your clinical trials.
Analysis of similar events (AoSEs)
“Smart Analysis. Stronger Safety”
The Analysis of Similar Events (AoSE) for SUSARs is a systematic process used in pharmacovigilance to identify patterns or trends in adverse events reported during clinical trials. FDA, EMA, and MHRA, require AoSE to ensure that investigational drugs are monitored rigorously for unexpected safety risks.
The analysis must be thorough, transparent, and documented in accordance with Good Pharmacovigilance Practices (GVP) and International Council for Harmonisation (ICH) guidelines (e.g., ICH E2A, E2D). This involves comparing the index SUSAR with other similar cases based on factors such as demographic details, event characteristics, drug exposure, concomitant medications, and medical history.
The goal is to assess causality, detect potential safety signals, and ensure regulatory compliance. AoSE includes reviewing clinical trial databases, literature, and global pharmacovigilance repositories to identify related cases, using tools for statistical analysis and signal detection. The findings guide decisions on protocol amendments, updates to safety documents like the investigator’s brochure, and regulatory submissions, ensuring patient safety and adherence to guidelines.
Safety Management Plans (SMPs)
“Smart Planning. Safer Outcomes”
A Safety Management Plan (SMP) is an essential element of a robust pharmacovigilance program, detailing the processes and protocols for identifying, evaluating, and managing potential safety risks associated with a drug or therapeutic product. It ensures patient safety by identifying and managing potential safety risks.
It ensures compliance with regulatory requirements from the FDA and EMA, and also facilitates effective communication and collaboration among key stakeholders, including regulatory agencies, healthcare providers, and patient groups. We at CliniResource team can help you write a comprehensive Safety Management Plan as well as handle all drug safety activities during a clinical trial.
Expert Authoring of IBs, CSRs, and DSURs: Delivering Excellence and Precision
“The Importance of High-Quality Documentation.”
In clinical development, well-crafted regulatory documents such as Investigator Brochures (IBs), Clinical Study Reports (CSRs), and Development Safety Update Reports (DSURs) are critical. They communicate essential trial findings, ensure compliance with regulatory standards, and support decision-making at every stage of drug development. We assign experienced medical writers with deep knowledge of your therapeutic area.
Their understanding of disease pathology, clinical trial design, and treatment outcomes ensures the scientific integrity and relevance of your documents. Our team is well-versed in international guidelines, including ICH, FDA, EMA, and local health authority requirements. We ensure every document meets the highest standards for clarity, compliance, and format—tailored to your target markets.
Our rigorous quality assurance (QA) processes ensure that every document undergoes multiple layers of review for accuracy, consistency, and compliance. We deliver documents that are not only scientifically robust but also audit-ready. Choosing CliniResource means more than just outsourcing regulatory documentation—it means partnering with a team committed to your success.
Whether you need an expertly authored IB, CSR, or DSUR, we are here to deliver excellence with every project. Contact us today to learn how we can support your clinical development journey with industry-leading documentation solutions.
Scientific Publication Review During Development
“Excellence from the Start.”
In the development phase, scientific publications play a vital role in sharing insights, building credibility, and driving engagement with the research community. A meticulous review ensures your publications effectively convey the value of your findings while meeting the highest standards.
We specialize in reviewing publications tied to early and late-stage clinical development, ensuring alignment with your trial objectives and regulatory milestones. We’re your strategic partners in amplifying the impact of your scientific communications. Contact us today to ensure your publications make a lasting impression.
Signal Review During Clinical Trials
“Proactive Safety, Better Outcomes.”
Signal review during clinical trials is essential for identifying potential safety concerns early, ensuring participant well-being, and maintaining regulatory compliance. Timely and accurate signal detection protects your trial’s integrity and paves the way for successful development.
Our team of specialists brings in-depth knowledge of various therapeutic areas to contextualize and prioritize signals effectively. By providing actionable insights and recommendations, we help you address potential issues before they escalate. Contact us today to learn how we can safeguard your clinical trials.
Medical Monitoring
“Ensuring Safety, Compliance, and Success.”
A signal is any information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of aknown association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.
The existing pre-marketing/clinical trial procedures provide very limited information in terms of safety and efficacy of a drug, which is just about enough to obtain regulatory approval for drug marketing. Due to this, regulators in the post-marketing scenario often look for higher risk-based approaches to ascertain the benefit-risk profile of a product.
Greater the volume of data, greater the chances of regulatory happiness, but greater also are the chances of risks in the larger unexposed patient population. The balance is extremely precarious, and thus reliance on effective signal detection and management activities becomes the key factor in any effective pharmacovigilance system.
Our team at Clini Resource has delved deep into the intricate circuitry of drug safety systems, considering variable regulatory requirements globally and have come up with an innovative and proactive signal detection strategies using advanced analytics and data mining techniques. This can involve continuous monitoring of safety data to identify potential signals of emerging safety issues.
Our medics conduct in-depth analyses of various sources, including regulatory websites, published literature, database listings, and product surveillance programs and submit as valid standalone signal notification as applicable.