Your Trusted Partner For Clinical Research and Pharmacovigilance
CLINEXEL is a full-service CDSCO registered Clinical Research Organization (CRO) supporting sponsors with clinical trial planning, project management, site selection, regulatory coordination, clinical trial monitoring and clinical research services across global markets.
Our experienced clinical research professionals and qualified specialist vendors support clinical development programs from feasibility and study start-up through monitoring, data management and Clinical Study Report (CSR) writing.
CLINEXEL supports Phase I–IV and First-in-Human clinical trials involving small molecules, biologics, biosimilars and medical devices across multiple therapeutic areas.
Clinical trials require coordination across feasibility, sites, investigators, regulatory requirements, vendors, patient recruitment, monitoring, data and study documentation.
CLINEXEL brings these activities together through a full-service CRO model designed to support sponsors throughout the clinical development process.
These professionals work as part of CLINEXEL's in-house team, supported by qualified specialist vendors where required.
CLINEXEL’s team includes:
CLINEXEL supports clinical development programs across international markets and works with local CRO partners where on-the-ground capabilities are required.
The company describes its global clinical development model as supporting multiregional clinical trials through its AICROS network.
CLINEXEL's clinical research team works according to applicable ICH-GCP principles and relevant local regulatory requirements.
CLINEXEL provides site identification and feasibility support, including assessment of recruitment potential, timelines and operational considerations.
Sponsors can engage CLINEXEL for coordinated full-service clinical trial execution or selected clinical research functions according to study requirements.
CLINEXEL provides Clinical Trial Management Services covering key activities from study planning through close-out.
Our clinical trial project management capabilities include:
High-quality clinical trial monitoring supports protocol compliance, site oversight, patient safety and reliable clinical data.
Our monitoring approach focuses on appropriate site oversight, study documentation, protocol compliance and data quality throughout the clinical trial lifecycle.
CLINEXEL provides:
We assess study requirements, potential countries and sites, recruitment considerations, timelines and operational requirements.
Potential countries, investigators and clinical research sites are identified and evaluated according to study requirements.
Regulatory and Ethics Committee documentation is prepared and coordinated according to applicable requirements.
Selected sites are qualified, activated and prepared for study execution.
Recruitment planning and site-level activities are coordinated to support study enrollment.
Sites are monitored throughout the study to support protocol compliance, appropriate documentation and data quality.
Project teams coordinate sites, vendors, regulatory activities, study timelines and operational issues.
Close-out activities are coordinated according to study requirements, including documentation and site-level completion activities.
Clinical development increasingly involves multiple countries, regulatory environments and patient populations.
CLINEXEL supports Global Clinical Trials through its clinical research capabilities in India and its network of qualified local CRO partners.
As a full member of AICROS (an alliance of international CROs supporting multiregional clinical trials) CLINEXEL can conduct and coordinate clinical trial activities in markets where direct CLINEXEL presence is not available.
CLINEXEL can support Multiregional Clinical Trials (MRCTs) where studies are conducted across multiple countries or regions.
Our approach considers country-specific regulatory requirements, site capabilities, patient populations and operational requirements within the overall study strategy.
CLINEXEL supports clinical development programs across the clinical trial lifecycle.
Support for early clinical development and First-in-Human studies involving healthy volunteers or patients, as applicable to the study.
Clinical development programs focused on evaluating safety, efficacy and dose-related objectives.
Larger clinical development programs designed to further evaluate the safety and efficacy of investigational products.
Post-approval studies and additional clinical research conducted after commercialization, according to study objectives.
CLINEXEL has experience supporting clinical development involving:
Clinical development programs involving conventional pharmaceutical compounds.
Clinical research programs involving biologic products.
Clinical development and research programs involving biosimilar products.
Clinical trials and clinical evaluation activities involving investigational medical devices.
CLINEXEL supports clinical research programs across multiple therapeutic areas.
Our clinical research teams and qualified partners can support study-specific requirements based on the protocol, patient population, product type and applicable regulatory environment.
Sponsors need a CRO partner that understands the operational requirements involved in taking a clinical study from planning through execution.
CLINEXEL combines:
Integrated support across clinical trial management and clinical research activities.
CRAs, Trial Monitors, Medical Monitors, Project Managers and Medical Writers.
Site identification and feasibility capabilities to support recruitment and study planning.
Experience working with applicable global and local clinical research requirements.
The ability to support study requirements through in-house teams and qualified specialist vendors.
Operational planning designed around study requirements, timelines and sponsor objectives.
CLINEXEL’s clinical research capabilities are supported by quality certifications, industry memberships and recognition.
CLINEXEL’s current site identifies ISO 9001:2015 certification and ISO/IEC 27001:2022 certification.
CLINEXEL identifies itself as a CDSCO-registered CRO supporting clinical research in India.
CLINEXEL is a member of the Association of International Contract Research Organizations (AICROS), supporting its international CRO collaboration model.
CLINEXEL’s current service page identifies recognition including:
A Clinical Trials Organization or Contract Research Organization (CRO) supports sponsors in planning and executing clinical research. Services can include feasibility, site selection, regulatory coordination, project management, clinical trial monitoring, data management, medical writing and study close-out.
Whether you are preparing a First-in-Human study, Phase I–IV clinical trial or multiregional clinical development program, CLINEXEL can support your study with clinical trial management, feasibility, site selection, regulatory coordination, monitoring and clinical research services.
Talk to our clinical research experts about your study requirements.