Your Trusted Partner For Clinical Research and Pharmacovigilance
CLINEXEL is a pharmacovigilance services provider in India offering end-to-end drug safety and pharmacovigilance support for pharmaceutical, biotechnology and healthcare companies.
Our pharmacovigilance team supports safety operations across the product lifecycle, from ICSR processing and literature monitoring to signal detection, aggregate reporting, risk management, PSMF, QPPV and local safety services.
With experience supporting Indian and international pharmacovigilance requirements, CLINEXEL provides scalable and quality-focused PV solutions aligned with applicable regulatory requirements and Good Pharmacovigilance Practice (GVP).
Effective pharmacovigilance requires more than processing adverse event reports. Sponsors need an integrated safety system covering case management, medical review, regulatory reporting, signal detection, risk management and ongoing compliance.
CLINEXEL provides coordinated pharmacovigilance services designed around these requirements.
Our services cover the key stages of pharmacovigilance operations, from individual case processing to aggregate safety evaluation and compliance.
CLINEXEL's pharmacovigilance team has experience with safety operations and GVP-related requirements across international markets. Its current service materials reference experience involving regulatory environments including the US FDA, Health Canada, TGA, EMA, MHRA and BfArM.
CLINEXEL is led by professionals with pharmaceutical and biotechnology industry experience, supported by physicians, pharmacists and scientific professionals.
Sponsors can engage CLINEXEL for specific PV activities or broader end-to-end pharmacovigilance operations according to their product portfolio and market requirements.
CLINEXEL provides pharmacovigilance services across clinical development and post-marketing safety activities.
End-to-end individual case safety report management, including:
CLINEXEL’s current service scope includes physician review of cases and a stated 100% QC check.
Our literature monitoring services include:
CLINEXEL supports:
Our team supports authoring and production of applicable periodic safety reports, including:
We also support reporting calendar management and compliance monitoring.
CLINEXEL supports:
CLINEXEL provides:
CLINEXEL provides QPPV and Local Safety Officer support for applicable markets.
Its current representative-services offering identifies:
CLINEXEL supports:
Our quality and compliance services include:
Pharmacovigilance requirements vary across countries and regulatory jurisdictions. Companies operating internationally therefore need safety processes that can accommodate regional requirements while maintaining consistent global oversight.
CLINEXEL supports global pharmacovigilance operations for sponsors managing safety activities across multiple markets.
Our international PV capabilities include support for:
Depending on the product and market, services may include:
CLINEXEL’s representative-services offering currently identifies EU-QPPV, EU Local Safety Officers, India PV support, US agent support and QPPV services for Africa, Middle East and CIS countries.
Our global approach allows sponsors to coordinate local and international PV activities through an integrated service model while adapting execution to applicable regulatory requirements.
Pharmacovigilance begins during clinical development and continues throughout the product lifecycle.
CLINEXEL supports drug safety activities during clinical trials, including:
These capabilities are part of CLINEXEL’s existing clinical-development pharmacovigilance offering.
CLINEXEL provides support for the management of serious adverse events throughout applicable clinical development programs.
Activities can include:
A robust PV system requires documented processes, trained personnel, quality oversight and continuous compliance monitoring.
CLINEXEL supports sponsors with PV quality activities including GVP audits, gap assessments, SOPs, CAPA support, compliance metrics, inspection-finding management and vendor/partner audits.
The objective is to help sponsors maintain pharmacovigilance processes that are appropriately documented, monitored and aligned with applicable requirements.
Pharmacovigilance requires specialized medical, safety, regulatory and operational expertise.
Outsourcing can allow pharmaceutical and biotechnology companies to access experienced PV resources while scaling operations according to their product portfolio and geographic requirements.
CLINEXEL can support sponsors with:
Whether you require support for a specific PV activity or a broader safety program, the scope can be tailored to your requirements.
CLINEXEL supports organizations involved in pharmaceutical and biotechnology development and commercialization.
Our PV capabilities can support:
For ongoing drug safety, regulatory reporting and post-marketing pharmacovigilance requirements.
For emerging products requiring scalable pharmacovigilance capabilities during development and commercialization.
For sponsors entering new markets and requiring local PV, QPPV, LSO or regulatory coordination.
For safety management and reporting throughout clinical trials.
Safety information is received and assessed according to applicable processes.
Cases are triaged, entered, coded, medically reviewed and quality checked.
Applicable reportability and submission requirements are evaluated.
Additional information is obtained where follow-up is required.
Literature, individual cases and aggregate safety information are continuously evaluated.
Potential safety signals are identified, assessed and documented.
Identified and potential risks are evaluated and appropriate risk-minimization activities are supported.
PV processes, metrics, audits and quality activities are monitored throughout the program.
CLINEXEL is a professionally managed CRO led by professionals with experience in pharmaceutical and biotechnology organizations.
Its team includes physicians, pharmacists, doctorates, graduates and postgraduates in science with hands-on industry experience.
CLINEXEL also describes its broader CRO model as providing end-to-end clinical development, clinical operations, regulatory affairs, medical writing and pharmacovigilance services.
This integrated capability can help sponsors coordinate pharmacovigilance with clinical development, regulatory and medical-writing activities when required.
Pharmacovigilance is the science and activities involved in detecting, assessing, understanding and preventing adverse effects and other medicine-related safety problems.
A pharmacovigilance service provider supports pharmaceutical and biotechnology companies with activities such as ICSR processing, medical review, literature monitoring, signal management, aggregate reporting, risk management and regulatory compliance.
CLINEXEL provides ICSR processing, literature monitoring, aggregate reporting, signal detection and management, RMP services, PSMF services, QPPV and Local Safety Officer services, SDEA support, PV quality and compliance services and safety writing.
Yes. CLINEXEL supports pharmacovigilance activities across India and international markets through its PV operations and regional representative capabilities.
Yes. CLINEXEL provides EU-QPPV/QPPV and Local Safety Officer services for applicable markets.
ICSR processing involves receiving, triaging, entering, coding, medically reviewing, assessing, quality checking and, where applicable, submitting individual safety reports to regulatory authorities.
Aggregate safety reports periodically evaluate accumulated safety information for a medicinal product. Examples include PBRERs, PSURs, PADERs and DSURs, depending on the applicable regulatory requirements.
Yes. CLINEXEL provides GVP audits, internal audits, self-inspections, vendor audits and partner audits as part of its PV quality and compliance services.
Whether you need ICSR processing, literature monitoring, aggregate reporting, signal management, RMP, PSMF, QPPV, Local Safety Officer or broader pharmacovigilance operations, CLINEXEL can provide scalable support for your safety and compliance requirements.
Talk to the CLINEXEL team about your product, markets and pharmacovigilance requirements.