Clinical Study Management

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We manage full life cycle clinicals trials for Phase I – IV Studies. We also support Investigator Led Trials. All our engagements are supported by robust SOPs with due attention to protocol adherence and GCP Compliance. Our Engagements commence with support for sites selection and conclude with the final CSR

Clinical Operations

Study Start-up Activities:

At Nextvel, we understand that a successful clinical trial begins with a well-executed study start-up phase. Our clinical study management services cover all aspects of clinical operations for drugs, devices, IVDs (in-vitro Diagnostic Devices), and SaMDs (Software as Medical Device). Our team of experts provides comprehensive support for all study start-up activities, which involves all the activities and tasks that need to be completed before patient enrolment can begin. This critical period sets the foundation for the entire study ensuring that your trial gets off to a strong start and sets the stage for a smooth and efficient execution. We perform the following activities as part of Study Start-up

Feasibility Assessments
Site Selection and Qualification
Ethics Submission Coordination
Collection of Regulatory /Essential Documents
Contract and Budget Negotiation with sites and vendors
Investigator Site Training
Setting up Study Filing
Clinical Trial Registration

During the Study

We provide comprehensive services throughout the duration of the clinical trial to ensure smooth execution, data quality, and regulatory compliance. Our team of experienced professionals is dedicated to optimizing the efficiency and success of your study. We undertake the following:

Risk Based Monitoring
Site and Remote Monitoring
Investigational Product Management and Accountability
Safety reporting
Ensuring Protocol and Regulatory Compliance
Data Collection and Query resolutions
Project Management throughout the life cycle of the project

Data Management and Biostatistics

We understand that data management and biostatistics are essential for the success of any clinical trial. Our team of experienced data managers and biostatisticians provide comprehensive services to ensure that your study data is accurately collected, cleaned, analysed, and reported. We undertake the following:

Validate the database
Prepare Data Management Plan and Statistical Analysis Plan
Study Database Design, Testing, Validation, and Implementation
Data Cleaning and Resolution:
Statistical Programming and Analysis

Report Compilation

At Nextvel, we understand the importance of accurate and compliant clinical study reports (CSRs) for the success of your clinical trial. Our team of medical writers and regulatory experts provide comprehensive report compilation services to ensure that your CSRs meet the highest standards of scientific and regulatory rigor. Our reports are compliant with:

ICH E3 Requirements
Indian Regulatory Requirement

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