Your Trusted Partner For Clinical Research and Pharmacovigilance
Developing a pharmaceutical, biotechnology, or medical device product across multiple countries requires coordinated clinical, regulatory, operational, and scientific planning. CLINEXEL provides Global Clinical Development Solutions that help sponsors plan and execute international clinical development programs across different regulatory environments, healthcare systems, patient populations, and clinical trial requirements.
Our global clinical development approach integrates clinical development strategy, regulatory planning, clinical trial execution, country selection, site feasibility, project management, medical writing, data management, safety and other clinical development activities according to the needs of each program.
CLINEXEL supports pharmaceutical, biotech and medical device companies from early clinical development through by identifying the most suitable countries for early clinical development and ability to run clinical operations in 80+ countries. For late-stage clinical development -strategy for Phase 3 clinical studies is developed to optimize the time and cost. Several factors are considered including agency approval time, standard of care, feasibility of protocol harmonization and clinical operations.
. Through our international CRO collaborations and AICROS network, we can coordinate clinical research activities across multiple regions while maintaining a centralized project management structure.
Global development programs require more than conducting clinical trials in different countries. Sponsors need a coordinated strategy that considers regulatory pathways, operational feasibility, recruitment potential, clinical expertise, timelines, costs, data requirements, and local execution.
CLINEXEL combines clinical and regulatory expertise with AICROS experience to support multinational development programs.
Our team supports the development of clinical strategies aligned with target product profile, clinical development stages, regulatory expectations and target markets.
We support regulatory planning and coordination across jurisdictions, including drafting of briefing dossier, preparation for regulatory interactions and clinical trial application submissions.
CLINEXEL supports multiregional clinical trials (MRCTs) through AICROS, the collaboration that was established in 2013. AICROS members have conducted more than 60 studies together.
A centralized project management structure provides primary point of contact for the Sponsors. The Global Project Manager in turn coordinates with country based CRAs and vendors. Project Manager coordinates activities across participating countries, providing sponsors with a single point of contact.
Local CRO teams have strong knowledge of country-specific regulatory requirements, clinical practices, site capabilities, recruitment conditions and operational requirements.
Clinical development programs can be structured according to sponsor requirements, development stage, geography, therapeutic area and available resources.
CLINEXEL provides integrated clinical and regulatory support across different stages of the product development lifecycle.
A successful multinational development program begins with an appropriate clinical development strategy.
CLINEXEL supports sponsors with:
The strategy can be adapted according to the product, indication, development phase, target population and intended markets.
Early regulatory interaction can help sponsors refine their clinical development plans before major clinical commitments are made.
CLINEXEL supports activities including:
The existing CLINEXEL model specifically includes support for pre-IND and scientific advice meetings to help establish and refine clinical development and regulatory strategies.
International clinical development requires coordination between clinical strategy and local regulatory requirements.
CLINEXEL can support sponsors with:
Our broader regulatory capabilities can be integrated with clinical development activities to help maintain alignment between the clinical program and regulatory requirements.
Related service:
Multiregional clinical trials require coordination across countries with different regulatory requirements, clinical practices, healthcare systems and patient populations.
CLINEXEL supports MRCT programs through its participation in AICROS – Association of International Clinical Research Organizations.
According to CLINEXEL’s current service information, AICROS is an alliance of eight small and mid-size CROs, with members working together on Phase I–IV clinical trials, non-interventional studies and medical device clinical investigations. CLINEXEL states that the network provides coverage across more than 80 countries and four continents.
This model enables sponsors to access local clinical research capabilities while maintaining centralized coordination.
Country selection is an important component of multinational clinical development.
CLINEXEL’s global clinical development model evaluates potential countries based on factors such as:
The objective is to identify countries that are operationally appropriate for the study rather than simply selecting the largest possible geographic footprint.
Once countries have been identified, appropriate clinical sites and investigators need to be evaluated.
CLINEXEL and its local CRO partners can support:
This local execution capability complements centralized global project management.
Managing multiple CROs and countries can create unnecessary communication and coordination challenges.
CLINEXEL’s AICROS model uses centralized project management, with one CRO coordinating the overall project while local CROs support activities such as regulatory submissions, site selection, monitoring and local study management.
Depending on the study requirements, centralized activities may include:
This structure provides sponsors with a single project management interface while leveraging local expertise in participating countries.
CLINEXEL can coordinate clinical operations across participating regions, including:
CLINEXEL’s broader CRO capabilities cover clinical trials from protocol preparation and regulatory/ethics approvals through monitoring, clinical data management and Clinical Study Report writing.
CLINEXEL supports clinical development programs involving different types of healthcare products.
Support for development programs involving new chemical entities, established pharmaceutical products and lifecycle development.
Clinical and regulatory support for biological products across relevant development stages.
Development planning and clinical research support for innovative biotechnology programs.
Clinical investigation and regulatory support for medical device development programs, including programs requiring evidence for international regulatory pathways.
Clinexel has partnered with biotech innovators to advance ATMPs, including cell-based, tissue-engineered, and regenerative therapies, combining scientific expertise, strategic regulatory insight, and agile clinical trial execution.
Clinexel team’s experience spans across complex generics, including long-acting injectables, implants, and specialized drug delivery systems, through tailored regulatory strategies, bioequivalence studies, and rigorous clinical development.
CLINEXEL has experience supporting clinical development across:
Early clinical development, including First-in-Human studies, healthy-volunteer studies and early safety/pharmacokinetic evaluation.
Patient-based clinical development focused on preliminary efficacy, dose selection and continued safety evaluation.
Larger confirmatory clinical trials designed to generate clinical evidence for regulatory submissions and product development.
Post-approval clinical development and post-marketing studies supporting the product lifecycle.
CLINEXEL states that it has experience conducting clinical trials across Phase I–IV, including First-in-Human studies in healthy volunteers and patients.
Global clinical development frequently requires multiple specialist functions to work together.
CLINEXEL can integrate clinical development with:
This integrated model can reduce fragmentation between individual service providers and allow development activities to be coordinated around the overall program strategy.
Related services:
International clinical development requires an understanding of both global standards and local requirements.
CLINEXEL’s global clinical development model combines its India-based clinical research capabilities with international CRO collaborations.
CLINEXEL provides local clinical research and regulatory support for sponsors conducting clinical development in India, including site selection, feasibility, regulatory and ethics submissions, monitoring and study coordination.
CLINEXEL supports global programs involving US regulatory and clinical development requirements, including IND-related activities and coordination with international development programs.
Clinical development programs involving European countries can be supported through regulatory planning, clinical trial application coordination and local CRO capabilities.
Through its international CRO network, CLINEXEL can coordinate clinical development activities across additional countries according to sponsor requirements and study needs.
The objective is not simply to add countries to a trial, but to create a coordinated development strategy that aligns regulatory, operational and scientific requirements across markets.
We assess the product, indication, development stage, target population, study objectives and intended markets.
We define the clinical development approach and identify relevant regulatory and operational considerations.
Potential countries are assessed based on regulatory requirements, recruitment potential, site capabilities, timelines, therapeutic experience and cost considerations.
The selected countries, clinical sites, regulatory strategy, operational model and study requirements are incorporated into the development plan.
Regulatory submissions, ethics approvals, site activities and other study-startup requirements are coordinated across participating regions.
Local CROs and clinical teams conduct study activities under centralized project management and agreed quality standards.
Clinical data management, statistical activities, medical writing, safety and reporting activities are coordinated according to the study scope.
Study outputs can support subsequent development decisions, regulatory interactions, lifecycle management or additional clinical development.
CLINEXEL combines the flexibility of an independent CRO with access to international clinical research capabilities.
AICROS provides access to established local CRO capabilities across multiple countries.
CLINEXEL's management and technical teams include professionals with pharmaceutical and biotechnology industry experience.
Clinical development can be coordinated with regulatory affairs, medical writing, pharmacovigilance and other clinical research functions.
Sponsors can engage CLINEXEL for specific development activities or broader end-to-end clinical development programs.
The model combines local country knowledge with centralized project coordination.
CLINEXEL emphasizes customized, regulatory-compliant and cost-conscious clinical development approaches for pharma, biotech and medical device companies.
Our services are designed for:
CLINEXEL currently identifies clients across India, Europe, the USA, Canada, Israel and Singapore.
Global Clinical Development Solutions are coordinated clinical, regulatory and operational services designed to support the development of pharmaceutical, biotechnology or medical device products across multiple countries and regulatory jurisdictions.
Global clinical development allows sponsors to plan clinical studies across appropriate countries and patient populations while coordinating regulatory, operational and scientific requirements for different markets.
Yes. CLINEXEL supports multinational and multiregional clinical trials through its clinical research capabilities and international CRO collaborations, including its AICROS network.
CLINEXEL’s international model provides access to CRO capabilities in the USA, Europe, India, Australia and New Zealand, Israel, Africa, China, South Korea, Turkey and many more countries. AICROS network extends across more than 80 countries and four continents subject to the specific study requirements and participating-country availability.
Yes. CLINEXEL has experience across Phase I–IV clinical trials, including First-in-Human studies in healthy volunteers and patients.
Yes. CLINEXEL provides end to end clinical research and regulatory support in India, including site feasibility site selection, regulatory approval with strong expertise with CDSCO approval process, and ethics documentation, trial monitoring, study coordination and other local clinical trial activities.
CLINEXEL’s global development model is designed to coordinate multinational programs using centralized project management and local CRO capabilities. The specific countries and activities are determined according to the sponsor’s development program and study requirements.
Yes. CLINEXEL integrates clinical development with regulatory affairs and can support activities such as development strategy, regulatory submissions, pre-IND/scientific advice preparation, clinical trial applications and ongoing clinical development activities.
Whether you are planning an early-phase international program, a multiregional clinical trial, an India clinical development program or a broader global development strategy, CLINEXEL can help coordinate the clinical, regulatory and operational components of your program.
Talk to our Global Clinical Development experts to discuss your product, target markets, clinical development stage and study requirements.