Simplifying the path
Clinical trials are a scientifically daunting process, and we help streamline the path for you. Harnessing the expertise of our team and their clinical research experience, Clicebo helps you drive operational excellence and deliver error-free results, on-time and within budget. We provide end-to-end solutions for your clinical research journey from Phase II to IV.
Clinical development capabilities
Accelerating study start-up is key to ensuring a seamless clinical trial and minimizing any study delivery delay. At Clicebo, we help you start your clinical study on the right foot. Leveraging our network of sites, strong database, and technology platforms, our team enables the successful delivery of your study through the following services -
- Study start-up and planning
- Study workflows and milestones
- Site identification, feasibility, and selection
- Essential document collection
- IRB/IEC submission
- Track submission/Approval status
- Contract and budget negotiation (CTMS – Study budget)
- Single application platform (CTMS)
- Site activation
- Regulatory packages distribution and submission
- Training on the study protocol, any specific laboratory procedures, and any specific instructions for CRF completion
As our partners in research, you get access to our experienced project management and clinical teams that go the extra mile in assisting you with integrated planning, design, and implementation of various stages of your clinical program.
Each project team is headed by a project leader who manages and coordinates the activities of a multi-functional team. This team comprises Clinical Research Associates (CRA), Clinical Trial Assistants, Data Managers, Biostatisticians, Medical Writers, Safety Team, Regulatory Professionals, and Vendors. Our project leaders will be accountable for all your project deliverables, implementation, tracking, and resolving all project-related issues. Simultaneously, the leaders also ensure proactive identification and resolution of potential issues to keep projects on track or ahead of schedule. They will help in conducting the following activities -
- Budgets and Clinical Trial Agreements (CTA) management
- Liaison with vendors
- Reporting on results
- Compliance enforcement
- Communication of study risks to seniors
- Site reports review and approval
Quality control is an integral part of a clinical trial, and our CRAs hold experience in various therapeutic areas and have undertaken vigorous training programs. They work closely with the project leader to ensure comprehensive planning, communication, and detailed documentation of all project activities. They oversee the progress of the clinical trial and ensure that it is conducted, recorded, and reported per the protocol, SOPs, GCP, and applicable regulatory requirements.
We provide the following types of solutions in Diagrammatic representations:
- Remote monitoring
- Routine Site monitoring
- Risk Based monitoring
- Centralized monitoring
Our medical experts and healthcare professionals provide medical monitoring services to avoid continuous oversight of the medical aspects of clinical studies and assistance to both in-house and on-site project teams. This process helps ensure high-quality conduct, documentation, and reporting aligned with industry regulations and in-house standards.
- Protocol synopsis, protocols, and amendments
- Informed consent forms
- Clinical Study Reports (CSRs)
- Safety narratives
- Clinical development plans
- Investigator brochures
- Patient information leaflets
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
Our medical experts and healthcare professionals provide medical monitoring services to avoid continuous oversight of the medical aspects of clinical studies and assistance to both in-house and on-site project teams. This process helps ensure high-quality conduct, documentation, and reporting aligned with industry regulations and in-house standards.
- Collection, evaluation, analysis, and reporting of safety information, including adverse events, unanticipated adverse device effects, and other significant safety events
- Safety narrative writing, including physician reviews
- Oversight of the safety of study participants
- SAE reporting and monitoring plan creation
- Sites training on SAE reporting
- SAE reports submission to concerned authorities
- Recording in the safety database
- MedDRA and WHO drug coding
- Case narrative writing
- Medical data review
- DSUR preparation and submission
- Aggregate reporting
- EudraVigilance reporting
- Preparation and submission of annual safety reports, six monthly line listings, and periodic reports
- 24/7 medical assistant for eligibility assessment, emergency un-blinding, and/or general study support