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Services

Functional Service Provisioning

VAICS specializes in Functional Service Provisioning (FSP) by offering a managed service model that integrates seamlessly with your clinical development processes. Unlike traditional contractor models, our FSP approach provides continuous, expert support tailored to your specific needs, ensuring optimal efficiency, compliance, and quality across all key functional areas.

Our key services

Comprehensive FSP/MSP solutions designed for excellence at a glance.

Clinical data management (CDM)

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Biostatistics and statistical programming

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Medical
writing

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Clinical
operations

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Clinical data management (CDM)

Our Expertise: VAICS excels in Clinical Data Management (CDM), delivering meticulous and efficient management of clinical trial data. Our FSP model ensures that your data is handled with the utmost accuracy and integrity from initial collection through final reporting.

Custom data management solutions

Developing tailored data management strategies and plans that align with your clinical trial objectives and regulatory requirements.

Advanced data collection and validation

Utilizing sophisticated electronic data capture (EDC) systems and validation techniques to ensure accurate and timely data entry.

Robust database design

Designing and maintaining comprehensive databases to facilitate efficient data storage, retrieval, and analysis.

Comprehensive data monitoring and query management

 Implementing continuous monitoring protocols to identify and resolve data discrepancies, ensuring the highest data quality throughout the trial.

Regulatory compliance and reporting

Preparing and validating data for regulatory submissions and audits, adhering to all relevant guidelines and standards to support regulatory approvals.

Biostatistics and statistical programming

Our Expertise: In Biostatistics and Statistical Programming, VAICS provides expert support for designing, analyzing, and interpreting clinical trial data. Our FSP services are designed to integrate seamlessly with your study processes, ensuring precision and regulatory compliance throughout.

Detailed statistical analysis plan (SAP) development

Crafting comprehensive SAPs that outline statistical methods and analysis strategies tailored to study objectives and regulatory requirements.

Expert statistical programming

Developing and validating statistical programs for data analysis, including generating Tables, Figures, Listings (TFLs), and ensuring accurate statistical reporting.

CDISC standards compliance

Ensuring adherence to CDISC standards, including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model), to facilitate regulatory submissions and meet industry standards.

Advanced sample size calculations

Conducting rigorous sample size estimations to determine the appropriate number of participants needed to achieve study objectives and ensure statistical power.

Interim and final analysis support

Providing expert support for interim analyses, Data Monitoring Committee (DMC) reviews, and final study reports, ensuring robust data interpretation and decision-making.

Medical writing

Our Expertise : VAICS offers specialized Medical Writing services through our FSP model, ensuring the creation of high-quality, regulatory-compliant documentation that clearly communicates study findings and supports successful regulatory submissions.

Regulatory documentation preparation

Crafting essential regulatory documents, such as Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), ensuring they meet all regulatory requirements.

Protocol and informed consent development

Drafting and revising clinical trial protocols and informed consent forms to ensure clarity, accuracy, and compliance with regulatory standards.

Scientific manuscript preparation

Assisting with the preparation of manuscripts for publication in peer-reviewed journals, including writing, editing, and submission.

Comprehensive document reviews

Conducting thorough reviews of clinical trial documents to ensure consistency, accuracy, and adherence to regulatory and industry standards.

Clinical operations

Our Expertise : VAICS provides end-to-end support for Clinical Operations through our FSP model, managing all aspects of clinical trial execution with a focus on operational efficiency, regulatory compliance, and high-quality outcomes.

Site management and monitoring

Overseeing clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements, including site initiation, monitoring, and closure.

Patient recruitment and retention

Implementing effective strategies for recruiting and retaining study participants, ensuring that enrollment targets are met and trials are completed on schedule.

Project management

Managing all aspects of clinical trial projects, including planning, execution, and reporting, to ensure timely and cost-effective delivery.

Clinical trial documentation management

Preparing and maintaining essential trial documentation, such as trial master files (TMFs), to support regulatory submissions and audits.

Regulatory compliance assurance

Ensuring that all trial activities adhere to regulatory guidelines and industry standards, including compliance with local and international regulations.

Why choose VAICS for FSP?

VAICS’s Functional Service Provisioning (FSP) model offers a comprehensive and specialized managed service approach, providing expert support across Clinical Data Management, Biostatistics and Statistical Programming, Medical Writing, and Clinical Operations. Our FSP services are designed to seamlessly integrate with your clinical development processes, ensuring that your trials are conducted efficiently, effectively, and in compliance with all regulatory requirements. By partnering with VAICS, you gain access to a dedicated team of professionals committed to delivering high-quality results and driving the success of your clinical development programs.

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