Full Service CRO Clinical Trials Pharmacovigilance Global Clinical Development Regulatory Medical Devices Pharmacokinetic Studies
CLINEXEL is a Contract Research organization providing end to end services in Clinical development, Clinical operations, medical writing, and Pharmacovigilance. Our clients include Pharma, Biotech, and Medical Device companies based in India, Europe, US, Canada, Israel and Singapore.
Projects managed by CLINEXEL include design and execution of clinical trials across various phases, including
- Phase I (First in Man) studies in Oncology and Phase I study in Healthy Volunteers.
- Phase II & Phase III clinical trials for New Chemical Entities and for label update additional indication and route of administration (life cycle management).
- Post Marketing Clinical Follow up (PMCF) studies for medical devices.
- Expert clinical development solutions with successful negotiations with FDA, EU, WHO and DCGI for NCEs and biologicals.
- End to end pharmacovigilance operations.
Clinical Trials
CLINEXEL provides end to end services for conducting clinical trials starting from study design, feasibility studies and site selection, preparation of protocol and other essential documents, logistics and project management, clinical trial applications and approval, clinical trial monitoring, data management, statistical analysis and preparation of clinical study report.Read More
- Clinical Trials Project Management
- Clinical Trials Monitoring Services
Global Clinical Development
CLINEXEL supports companies by-
• Development of efficient clinical development plans acceptable to different regulatory authorities
• Facilitating pre-IND, End of Phase and pre-NDA submission meetings with regulators to develop and fine tune clinical development plan
• Filing and maintaining IND in US, clinical trial applications in EU and India
• Global solutions for CLINEXEL clients through world-wide clinical trials. Read More
•CLINEXEL is a member of Association of International Clinical Research Organizations or AICROS .
Pharmacokinetic Studies
CLINEXEL Team members have extensive experience in Pharmacokinetic studies in healthy volunteers and patients. Cumulative experience of the team spans ~800 studies for various markets, including PK studies in healthy volunteers, patients for Long Acting Injectables, biosimilars and inhalation products. Read More
Medical Devices
•Preparation of Protocols, Informed Consent Forms, and Investigators’ Brochure
• Preparation of Clinical Study Reports
• Authoring Clinical Evaluation Reports including literature search protocol, PICO analysis
• Post Marketing Clinical Follow-up Plans. Read More
Regulatory Affairs
At CLINEXEL, we are providing global clinic-regulatory services to companies for the development of their new chemical entities and biologicals. We have supported companies for pre-IND and scientific advice meetings for firming up their clinical development plans and regulatory strategies. We are also working on subsequent IND projects for Life Cycle Management of pharmaceuticals. Read More
- Medical Writing
- Representative Services
Pharmacovigilance
CLlNEXEL is currently supporting 7 Pharma companies for Pharmacovigilance as below:
End to end PV operations for US FDA and India, including case processing, periodic reports, literature monitoring, signal detection, preparation of risk management plan and evaluation of additional pharmacovigilance activities and additional risk minimization measures. Read More
- End to end Pharmacovigilance Operation services
- Drug Safety in Clinical Development
- Study start up activities
- Serious Adverse Event Management
- End of Study Activities
- Medical Writing for Drug Safety
Why choose us?
One Stop Solution
- We provide end to end services and cover the full array of Clinical Research and Pharmacovigilance activities
- Safety database, EDC systems, Local Agent, QPPV and local trial monitoring services globally provided together with our partners
- We have pre-qualified technology partners and logistics partners
Experienced Team
- Our team has 150+ years of collective experience
- Strong TEAM of experts with proven track record in Pharma Companies
- Senior Management directly involved and provide governance for all projects
- Local Expertise with experience of working in Global Projects and with cross cultural teams
Scalable Solution
- Experienced team leaders and Strong procedures at CLINEXEL facilitate fast and efficient scale-up
- Ability to rapidly scale -up including additional infrastructure, expert resources and project training
- Based on client requirements, WE can quickly scale-up our services by hiring additional staff as well as through process automation and cognitive automation
Personalized Attention
- We understand that each trial is unique requiring detailed attention to assess potential risks and plan distinctive solutions to minimize risks
- We provide customized solutions to our Clients ranging from full service operations to specific functional services
Senior Management with technical expertise and experience
- CLINEXEL Senior Management have worked in leadership positions in core Pharma, therefore, they have Strong understanding of the drug development processes from start to finish, and the relevant global regulatory requirements
- CLINEXEL core team is well versed with regulatory requirements, GCP, and GVP and applicable regulations.
- Regular Training by Senior team members ensures that all team members are regularly trained for all new and revised regulations and guidelines.
GDPR Compliance
- At Clinexel, we have a comprehensive privacy program that is designed to respect and protect the personal data that we process, including all data processed on behalf of our clients.
ISO Certified
(ISO 9001:2015:QMS)
(ISO / IEC 27001 : 2013 :ISMS)
Association of International Contract Research Organisationss
CLINEXEL Is a member of AICROS
