Biostatistics and Analytical Services

At RCS, our Biostatistics and Analytical Services are at the core of delivering data-driven insights for clinical research. We provide comprehensive statistical expertise to ensure that your clinical trials and research studies are scientifically sound, robust, and compliant with global regulatory standards. from simple Phase I-II to highly complex, global Phase II-IV trials and registries. Our team has experience with adaptive designs, independent reporting to Data Monitoring Committees (DMCs) and Data and Safety Monitoring Boards (DSMBs), production of CDISC compliant deliverables such as SDTM and ADaM datasets, metadata, and reviewer’s guides and PK/PD analyses.

Our experience across numerous therapeutic areas is complemented by specialist expertise in vaccines, infectious diseases, substance use disorder, neurology/mental health, ophthalmology, oncology, maternal and child health, transplant, allergies, autoimmune disorders and gene/cell therapies.

• 17 years of expertise in SAS and R-Programming

• Experienced pool of biostatisticians and statistical programmers

• Global delivery model

• High quality output with accuracy

• Global Regulatory Submissions Support

• Expert knowledge of wide Therapeutic Areas & Regulatory Standards including (cGCDMP, 21 CFR Part 11, CDISC/CDASH, SDTM, ADaM, HIPPA)

Services

Statistical Inputs to the Protocol

With over 15 years of experience, our statisticians provide expert input to optimize study protocols, ensuring scientifically robust design and regulatory compliance. This input enhances trial efficiency and data quality from the beginning.

Sample size calculation

Our team performs accurate sample size calculations to ensure studies are appropriately powered. Leveraging tools like SAS9.4, Nquery, and SYSTAT, we help optimize enrollment and resource use.

Review of CRF

We meticulously review Case Report Forms (CRF) to ensure accurate, relevant, and consistent data collection. Our experts ensure that the CRF aligns with the statistical objectives and regulatory standards.

Development of Statistical Analysis Plan (SAP)

We develop detailed Statistical Analysis Plans (SAP), using our 15+ years of experience with SAS and R-programming to define methodologies for accurate data interpretation and regulatory compliance.

Randomization and Unblinding

Our statisticians create secure, randomized schedules and manage unblinding procedures, ensuring unbiased study results. We use advanced tools like Neural Connection for complex randomization needs.

Preparation of CDISC Compliant Datasets (SDTM, ADaM)

We prepare CDISC-compliant datasets, including SDTM and ADaM, using our expertise in SAS, SPSS, and WinNonlin, ensuring smooth regulatory submissions and global standard adherence.

Statistical Analysis and Interpretation

We conduct rigorous statistical analysis and provide insightful interpretations of clinical trial data. Our 15+ years of experience ensures that analyses using SAS, SPSS, and other tools lead to actionable clinical insights.

 Clinical Study Reports

Our team delivers high-quality Clinical Study Reports (CSR), integrating statistical findings into clear narratives. With expertise in SAS9.4 and SYSTAT, we ensure reports meet regulatory requirements and industry standards.

Interim and Final Analysis (SAS, SPSS)

With deep expertise in SAS, SPSS, and WinNonlin, our team performs statistical programming for both interim and final analyses. We ensure accurate, reliable results at all stages of your clinical trial.

Empowering clinical trials with expert biostatistical analysis and data-driven insights for global success

• Experience and Expertise: With decades of industry experience, our statisticians bring a wealth of knowledge and expertise to every project, ensuring robust statistical solutions and actionable insights.

• Customized Solutions: We collaborate closely with our clients to understand their unique needs and tailor our services accordingly, providing customized solutions that meet and exceed expectations.

• Quality and Accuracy: We prioritize quality and accuracy in all our statistical analyses and reporting, adhering to industry standards and best practices to deliver reliable and robust results.

• Timely Delivery: We understand the importance of timeliness in clinical research, and our team is committed to delivering results on time and within budget, helping you meet your study milestones and objectives.

Our Specialty