End‑to‑End Medical Monitoring Services
Ensure the safety and integrity of your trial with expert guidance. With diverse therapeutic backgrounds and regional expertise, our medical monitors provide rigorous oversight.
- Study protocol, informed consent forms, and risk assessment input
- Bespoke training for investigational sites and study teams
- Support for queries about eligibility, safety, and other site needs
- Patient data review to identify trends and risks
- Review, coding, and narrative writing for serious adverse events (SAEs)
Agile Clinical Safety & Pharmacovigilance
Choose flexible, cost‑effective solutions rooted in thorough risk‑benefit assessments. Backed by 20+ years of safety management experience, we minimize risks without compromising scientific integrity.
- Comprehensive safety oversight across the product lifecycle
- Streamlined, automated safety and pharmacovigilance processes
- Exhaustive risk management and mitigation
- Phase I‑IV commercial and academic clinical research experience
- 24‑hour help desk, accessible by email and mobile
Post‑Marketing Pharmacovigilance Services
Safeguard patient well‑being with industry‑leading post‑marketing surveillance, ensuring early identification of safety concerns for continuous regulatory compliance.
- Individual case safety report (ICSR) management
- Proactive approach for early signal detection and risk management
- Global literature surveillance to identify and report safety signals
- Pharmacovigilance system master file (PSMF) preparation
- Aggregate reporting for benefit‑risk assessment per ICH guidelines
Safety Solutions From Phase I to Post‑Market
With a deep understanding of your product and its safety profile, we offer flexible pharmacovigilance services to meet your unique needs, whenever and wherever you need us.
Through expert medical monitoring services, we provide real‑time safety oversight, prepare development safety update reports (DSURs), and perform safety regulatory reporting.
We also support medical device trials with technical document preparation and compliant US and EU MDR and EU IVDR reporting.
Streamlined Safety Data Management
We simplify case management and reporting with Oracle® Argus, a scalable, 21 CFR Part 11‑compliant safety database that consolidates data and integrates with your tools.
Machine learning and automation reduce costs, speed up data processing, and ensure data integrity—freeing you to focus on innovation.
Case Study
Driving Change in Rare Disease Research
We provided a full service for a Phase II open‑label osteosarcoma study, including medical monitoring and pharmacovigilance services.
With a rare indication and a young adult population, experience and precision were vital to ensuring patient well‑being and delivering reliable insights.
- Comprehensive real‑time patient safety monitoring
- Site training and close monitoring to ensure safety best practices
- Flexible, agile solutions to proactively address safety issues
Through rigorous safety oversight and rapid custom support, we advanced meaningful research for this rare and challenging disease.
See our impact in actionFrequently asked questions
What steps do you take to ensure compliance with evolving regulations?
We monitor regulatory changes globally and adapt safety and pharmacovigilance strategies to maintain compliance. Our dedicated team stays updated on evolving standards, liaises with local authorities, and proactively adjusts documentation, processes, and timelines so you can be confident that your trial and documentation align with the latest requirements in every region.
How do you ensure secure, compliant safety data management?
We use Oracle® Argus, a 21 CFR Part 11‑compliant safety database that adheres to global data privacy regulations. Aligned with GxP and ICH E2B (R3) standards, this scalable platform ensures accurate, efficient, cost‑effective case management and reporting.
What therapeutic areas do you support with medical monitoring and pharmacovigilance services?
With diverse therapeutic expertise, we’re your partner in advancing impactful therapies that transform lives worldwide. We deliver innovative, patient‑focused clinical safety and pharmacovigilance solutions across a wide range of therapeutic areas, from neurology and respiratory diseases to endocrinology and medical devices, with specialized leadership in renal, cardiometabolic, and oncology trials. Visit Therapeutic Expertise for more information.
Can you deliver safety and medical monitoring services for multi‑national or global trials?
Absolutely. We have a strong presence worldwide with on‑the‑ground teams in 40+ locations and established roots in the APAC region. Our expansive network of dedicated medical monitors and safety experts ensures real‑time patient safety oversight, adherence to global and local regulations, and accurate, secure safety data management. Our local experts speak your language, ensuring smooth communication and culturally sensitive, effective safety and pharmacovigilance services.
Related Services
Clinical Trial Monitoring
Ensure trial success with expert monitoring and site management, safeguarding data integrity and patient safety through local expertise and oversight.
Regulatory Consulting
Navigate the regulatory landscape with our global team, delivering tailored strategies and efficient clinical trial management from start‑up to safety reporting.
Endpoint Adjudication
Generate reliable, unbiased data and advance your study to the next milestone with support from global experts and efficient workflows tailored to every program.
Medical Writing
Get accurate, compliant documentation for every trial. We combine local expertise with a global perspective to deliver success, from protocol development to regulatory submission.