Sardonyx Solutions Inc.
A Global North American CRO for your Pharmaceutical research needs
Clinical & Post-Market CRO Accelerating Drug Development
We are a North American pharmacovigilance services provider and a CRO that provides comprehensive solutions across drug development and post-marketing phases. Our services include clinical & Post-marketing Pharmacovigilance, Medical writing, MICC, Call Centre, Quality Management Systems (QMS), and more.
Pharmacovigilance Services
Over 3 Decades of combined expertise to work for you. Our extensive skill set in various therapeutic areas enable us to understand your specific needs and deliver the work for your organization
ICSR Case Processing
Our team of drug safety experts provide the best ICSR Case processing with trackable case quality.
Our PV experts perform the Data collection, Triage, Data entry, MedDRA coding, narrative writing, medical assessment, and expedited reporting of individual case safety reports (ICSRs) for both clinical trial and post-marketing cases.
Literature Search Services
Our systematic global and local literature monitoring services are customized to support ICSR screening and signal detection, as well as to aid in 'Watch-list of events' management and enhance the benefit-risk profile of your medicine.
Our team of multidisciplinary Literature Search experts conducts end-to-end safety surveillance activities using a range of global biomedical databases, both commercial and publicly available, such as Medline, PubMed, and Embase, while also monitoring social media platforms.
All identified articles and abstracts undergo thorough review by our medical reviewers to support clinical trial and post-marketing activities, such as;
• Identification of ICSRs
• Identification of same or similar events of interest
• Tracking and reviewing of signal events for benefit-risk profiling
• Identification and categorization of important medical events
• Preparation of case reports for database purposes
Aggregate Reporting
Our experts can manage all Aggregate Report writing assignments which are required during clinical development, and post marketing. We have a though understanding of the DLP calendar, Annual and periodic reports requirements.
Our expertise are;
- DSUR (Development Safety Update Reports)
- PSUR (Periodic Safety Update Reports)
- PBRER (Periodic Benefit-Risk Evaluation Reports)
- PADERs (Periodic Adverse Drug Experience Reports)
- Addendum to the Clinical Overviews (ACOs) for module 2.5 for MA renewals
- RMP (Risk Management Plans) as per the EU-RMP template and region-specific appendices
- REMS (Risk Evaluation and Mitigation Strategies) as per US FDA requirements
Medical Information Call Center
Our expert Medical Information or contact center professionals can manage consumer calls, response management, query handling of potential adverse events (AEs) and Product Quality Complaints (PQCs)..
Our streamlined processes are;
- Call handling, Webmail, Chatbot monitoring, emails, physical letters etc.
- Collect, analyze, and respond with medical information as per the package insert and medical affairs SOPs
- Identify and track relevant safety information such as AEs, off-label use, medication errors, misuse, etc.
- Create Follow-up, along with standard response, quality check, and reconciliation of MI events
- Product quality complaints (PQC) and follow-up, as per the requirements and QA trending
- General query handling of the company products