Our Services

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We provides expert biostatistics support for clinical trials, ensuring rigorous study design, accurate data analysis, and regulatory compliance. Our team specializes in statistical strategy, protocol development, adaptive trial designs, and regulatory submissions to maximize the success of your drug development program.

 We ensures high-quality, regulatory-compliant data management from trial design to study close. Our expert team delivers accurate, on-time results while maintaining rigorous FDA and EMA standards, including 21 CFR Part 11 and ICH-GCP compliance. We specialize in eCRF design, database builds, data review, query management, and database lock, ensuring seamless clinical trial execution.

 We leverages cutting-edge technology and metadata-driven tools to ensure high-quality, efficient, and cost-effective clinical and statistical programming. Our expert programmers deliver fully compliant datasets for regulatory submissions, supporting diverse therapeutic areas such as oncology, metabolic diseases, neurosciences, and cardiovascular conditions. Services include SDTM and ADaM creation, FDA advisory committee analyses, clinical study reporting, and risk-based study monitoring.

 We ensures seamless regulatory submissions by delivering fully CDISC-compliant data packages. With expertise in SEND, SDTM, and ADaM standards, we streamline data mapping, validation, and submission processes, supporting over 200 studies with high-quality, submission-ready datasets.

 We provides end-to-end support for regulatory submissions, ensuring compliance with FDA and EMA requirements. Our team specializes in preparing high-quality NDA and MAA submission packages, including statistical analyses, integrated summaries, and CDISC-compliant datasets to facilitate a smooth regulatory review process.

 We specializes in building Global Integrated Databases (GIDB) to standardize clinical data, ensuring consistency across drug development programs. A well-structured GIDB streamlines regulatory responses, safety surveillance, market analysis, and future trial planning—maximizing the value of your clinical data while accelerating approvals and commercialization.

 We ensures timely and accurate registration of your clinical trials on ClinicalTrials.gov, complying with all regulatory requirements. We manage protocol submissions, results reporting, and updates—helping sponsors maintain transparency, meet compliance deadlines, and support regulatory interactions.

 We offers comprehensive medical writing services throughout the drug development lifecycle, from Phase I to Phase IV, including clinical trial protocols, study reports, regulatory documents, and medical publications, all compliant with ICH guidelines and regulatory requirements.

We offers flexible Functional Service Provider (FSP) solutions, providing experienced professionals in biostatistics, programming, and data management to support your clinical development needs.   

Our scalable model enables seamless team integration, whether on-site, remote, or hybrid, with performance tracking and long-term partnerships to ensure efficiency and continuity.

 We provides expert project management services to ensure drug development studies are completed on time, within budget, and according to scope. Through proactive risk management, efficient resource allocation, and clear communication, we streamline all phases of the project, fostering long-term process improvements and sustainable success.

We offers comprehensive BIMO services to ensure compliance with FDA regulations, including audit readiness, site inspection support, and documentation review to help you maintain the highest standards of data integrity and regulatory adherence.

We provides expert pharmacokinetic (PK) and pharmacodynamic (PD) analysis to support dose selection, efficacy evaluation, and safety assessments. Our team delivers high-quality, regulatory-compliant analyses to guide data-driven decisions throughout drug development.