CliniResource
Explore the possibilities with CliniResource, where expertise meets innovation, and success is a shared journey.
Mail Us Today:
info@cliniresource.com
WhatsApp Us Today:
+44-7456631366
CliniResource LLP.
A distinguished consulting firm dedicated to delivering expert services in pharmacovigilance, clinical safety and medical affairs. We are specialised in guiding our clients through every stage of the drug development process, from initial concept to product registration, and beyond into comprehensive life cycle management.
At CliniResource, we understand the critical role that pharmacovigilance plays in ensuring the patient’s safety. Our seasoned team of professionals brings a wealth of experience and expertise to provide tailored solutions for regulatory compliance, risk management, and adverse event reporting. We are committed to assisting our clients in navigating the complex landscape of drug development with precision and confidence.
As a client-centric firm, we pride ourselves on fostering collaborative partnerships and delivering results that surpass expectations. Our commitment to excellence, coupled with a proactive approach to industry challenges, positions CliniResource as a reliable resource for organizations seeking top-notch support in pharmaceutical development.
Let The Numbers Talk
Consulting & Outsourcing Services
Clinical Safety & Compliance
- SUSARs Management
- Medical Adjudication of SAEs
- Analysis of Similar Events
- Safety Management Plans
- Authoring IBs, CSRs & DSURs
- Review of Scientific Publications
- Signal Review
- Medical Monitoring
Post-Market Safety & Compliances
- ICSR intake, processing, and submission
- Global and local literature monitoring
- Signal detection and management
- Eudravigilance and MHRA Portal Services
- PSMF/National PSMF
Medical Writing
- Benefit/Risk Reports
- Aggregate reports - PSURs, PBRERs, DSURs, ACOs
- Risk management plans (RMPs) and REMS
- Writing SOPs & technical documents – PV system setup
- Writing product information, PILs, SmPCs, CCDS
- Regulatory feedback
Regulatory Affairs
- Regulatory Strategy Development
- Regulatory Submissions
- Compliance Management
- Regulatory Intelligence
- Responses to Health Authorities
Medical Information
- Handling Product Inquiry, Product Complaint & PQC
- MICC
- Emergency Unblinding for Clinical Trials
- Subject Counselling
- Customised Responses to Queries
Medical Devices & Veterinary pharmacovigilance
- PMS System Set-up
- Incidents & Complaints Management
- Field Safety Corrective Actions Management
- Annual PMS Report & PSURs
- Trend Analysis
- Setting Up Veterinary Pharmacovigilance System and Compliances
Qualified Person for Pharmacovigilance (QPPV) Oversight
Supporting Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV) services in 20+ countries.
PV Retainer Support Services
Promoting the use of adept and highly trained pharmacovigilance (PV) retainer support for ensuring optimal safety and compliance standards.
Industrial Training & Certification
General PV / RA training
We provide range of pharmacovigilance or regulatory medical training.
Topic Specific Training
Our trained team can provide client requirement specific topic trainings.
Training On-site
Our trained team can visit the client on-site and conduct.
Training Certifications
Under development.
Audit / Inspection Readiness Training
Our experienced and expert team can help you ready for any pharmacovigilance.
Technical PV / RA training
We provide technical pharmacovigilance or regulatory training.
Unique Business Proposition
In-House
The Ability of our experienced resources to work on client owned PV system as their extended team.
Collaboration
Engaging with small & mid-size PV consultants and CROs to help them in business expansion.
Out-Source
Full PV system outsourcing and implementation.
Why Choose Us
What Sets Us Apart
Cost-Effective Excellence
We promise to offer saving of up to 50% of total operational cost including saving on individual assignments.
24/7 Communication
Round-the-clock availability of expert medical professionals working in all the time zones.
Global Presence, Local Expertise
Global presence in more than 20+ countries including EU, US, Canada, CIS & Asia Pacific.
All Expertise Under One Umbrella
Comprehensive solution partner for all your Clinical, Pharmacovigilance & Regulatory Affair needs throughout the life cycle of your medicinal product and medical devices.
Advance Technology
CliniResource leads the way in pharmacovigilance with cutting-edge technology driving efficiency, accuracy, and compliance by encompassing automated data capture, AI, and ML.
Tailored Excellence
Requirement based customised solution experts. CliniResource stands out in the professional landscape by embodying the core principle of Tailored Excellence.
Leadership Team
Request Info
Are you a pharmaceutical company navigating the complexities of drug development and patient safety?
CliniResource can be your trusted partner. Our team of seasoned pharmacovigilance experts offers unparalleled services, from pre-authorization activities to post-marketing signal management.
We understand the evolving regulatory landscape and have the experience to guide you through every stage of the drug lifecycle, ensuring compliance and minimizing risks.
Let us help you bring safe and effective medications to market with confidence. Contact us today to discuss your specific needs and learn how CliniResource can be your competitive advantage.
- Expertise Throughout the Drug Lifecycle
- Navigate Regulatory Complexities
- Minimize Risk and Maximize Success
- Gain a Competitive Advantage