Statistical Programming Services

Global Pharma Tek offers comprehensive Statistical Programming services tailored for Clinical Trials, ensuring accurate and reliable data analysis, reporting, and compliance with industry standards.

The team of experienced biostatisticians provides trial design consultation, statistical methodology recommendations, programming expertise, and reporting accuracy necessary to deliver your trial efficiently and on time.

Biostatistics & Statistical Programming

Statistical programming services provide expert data analysis and management, typically within the context of clinical trials. These services utilize programming languages like r or SAS to perform complex statistical analyses, generate tables, listings, and figures (TLFS), and ensure data integrity and compliance with regulatory standards. This expertise is crucial for the successful conduct and reporting of clinical trials, enabling researchers to draw meaningful conclusions from their data and advance medical research.

Statistical Table, Listing, and Figure ProgrammingData Monitoring ProgrammingAnalysis Dataset ProgrammingValidation of Statistical OutputsIntegrated Summary ProgrammingAd Hoc Programming

At CliniOps we offer you high-quality, cost-effective, best in class biostatistics services. We have rich experience in biostatistics analysis reporting. Our biostatistics services offer you accurate data analysis and the ability to comply with regulatory requirements. Our services include Trial Design, Randomization, Statistical Analysis Plan (SAP), Statistical Programming, Tables, Listings and Figures (TLFs) and Clinical Study Report (CSR) generation. We have extensive experience in designing, analyzing and reporting clinical studies across a broad range of therapeutic areas, supported by robust processes. Our deep regulatory knowledge domain expertise in biostatistics services helps you to navigate the complexities of study design, calculation of sample sizes, study randomization, Data Visualization etc. For any phase of drug development, our highly experienced biostatisticians and programmers work closely with the study team to develop study design, perform sample size calculation and power determination, develop randomization scheme, write statistical analysis section of protocols, and write SAP detailing statistical methodologies. The SAP includes detailed descriptions of data consistency checks, data listings, and tables and graphs. Our professional programmers create and finalize programming processes for data consistency checks, data listings, and graphics.

Clinical Statistical Programming

Revisit your Project from the Perspective of Statistical Analysis From conceptualization to the final analysis and interpretation of results, biostatistics impacts a clinical study at all stages Biostatistics is one of the most crucial elements for any successful clinical trial because it produces tested, science-based answers. With the data produced by biostatistics, facts and justifiable methods are easier to come by. Whether your project requires appropriate study design, selection of endpoints, correct analysis methods, sample size estimation, statistical programming,the ability to make sound decisions is vital to your success. Quite simply, math and science-based statistical analysis awakens that success. The key to making the right decisions As an international full service CRO, SIRO Clinpharmenables you to make befitting decisions regarding these crucial aspects by providing the full scope of statistical and programming services. Some of these services include: Protocol and SAP development Sample size estimation Data derivation and mapping to CDISC standards Output generation and analysis Full DMC support, including preparation of the DMC charter Interpretation of results and input to Clinical Study Reports Our Experience Our global department of experienced medical statisticians and statistical programmers have considerable ongoing experience in all aspects of statistical services including: Phase I to IV trials, including analysis of PK and PD parameters and quality of life data Non-interventional studies Integrated safety and efficacy summaries for submission SIRO Clinpharm's statistical expertise thoroughly covers all major therapeutic areas, including angesiology, cardiovascular diseases, metabolic disorders, oncology, urology and virology. Furthermore, our experts have a profound understanding of even the most complicated statistical methodologies and trial designs, including adaptive designs. Providing Solutions for your Study Our philosophy is to design customized solutions through flexible service models with rigorous quality control processes. We aim to exceed the expectations of our diversified client base that ranges from biotech companies to top-ten multinational pharmaceutical companies. Our innovative methods of designing customized solutions is one of the key reasons clients trust our companyto provide the medical services they need.

Development of study protocols Support in study design Definition of study objectives and endpoints Sample size determination and randomization plan Statistical analysis strategy and methodology Dedicated Phase I, BA/BE study support including pharmacokinetic (PK) analysis Preparation of statistical analysis plans consistent with ICH guidelines SAS programming Statistical analyses and reporting of study results Production of tables, listings and graphs in compliance with ICH guidelines Validated software: SAS 9.2 and WinNonlin 5.0.1

Delivering high quality data and analysis in a timely and cost-effective manner Sciformix delivers clinical biostatistics and statistical programming excellence across all phases of drug development in a wide range of therapeutic areas. Our biostatisticians and programmers have built a reputation of excellence by producing quality deliverables, maintaining the highest level of scientific integrity and being responsive, flexible and collaborative. Sciformix s data managers and biostatisticians, in collaboration with the statistical programmers, offer comprehensive services including: Biostatistics Input to Study Design (including adaptive designs) and sample size calculation SAP, mock tables and LoT Guidance to programmers and review of TLGs (tables, listings, graphs) Statistical report and input to CSR Response to requests and queries from regulators Pharmacometric and Pharmacodynamic analysis and modeling Interim analysis and support to data and safety monitoring boards (DSMBs) Exploratory analyses for publications, abstracts, and marketing, including meta analysis Programming Inputs into statistical analysis plan and mock tables Write programming plan, specifications, rulebook using CDISC (SDTM/ADaM)/sponsor specific standards Develop programs to perform required safety and efficacy analysis Validation and parallel programming Blinded data review Develop macros when possible, especially for safety analysis, using SDLC Develop programs to convert raw datasets to CDISC SDTM standards and mapping data across different standards Support the regulatory submissions by creating SAS xpt files and define.xml

Biostatistics & Statistical Programming

Sample size estimation Development of CDISC compliant SDTM and ADaM datasets for FDA submissions Generation of Tables, Figures and Listings from Phase 1 through Phase 4 studies Post-hoc analyses Extensively experienced in using of large disease specific databases for detection of treatment effect in subjects from early stage open label studies by using matched controls

Our teams are dedicated to designing project management solutions in order to guarantee reliable and timely completion of the milestones. Our focus is to ensure the integrity of your data and organize your results into a clear and result oriented presentation. Our statistical programming Services include pre-analysis, Analysis and post-analysis:Protocol/development/Sample/Size/PlanningAnalysis/plan/developmentRandomization/planning and implementationStrategic/development/consultingIndependent/DMC/SupportISS/ISE database/preparation and analysisDatamining/Exploratory/ analysisSAS Programming for interim and final analysisRegulatory and Advisory meeting supportProfessional one involved with their highly subject knowledge like Ph.D., or M.S. level, are familiar with regulatory requirements and skilled in robust statistical methodologies. Our statistical Programmers are highly flexible and experienced using SAS that enables our ability To generate and QA report summaries and listings to your specifications.

Biostatistics and Statistical Programming

At Ephicacy Biostatistics and Statistical programming are seamlessly integrated to produce high quality Statistical Services. Our experienced analyst pool have been exposed to multiple phases and multiple therapeutic areas across the drug development spectrum making them an ideal fit with existing project teams at customer sites or to form the basis of new teams. Whether we are using our internal global macro library, a customer s internal environment, or by developing customized software solutions, Ephicacy programmers and statisticians are well versed in providing validated results to clinical study reports and submission ready deliverables. With our objective of building expertise and delivering our value to customers, we constantly monitor and adopt the changing standards in the regulatory environment and technology applications. This enables us to provide cutting-edge value addition to our constantly honed services. Integrated Statistics and Statistical Programming service offerings are:

at karmic, we have a prolific bio-statistics and statistical programming group that is abreast with leading edge statistical and programming techniques for delivering quick and efficient analysis results. Some of the highlights of the practice are:karmic has a prolific body of 60+ statistical/analytical modeling, programming and analysis projects across phase i, ii, iii, iv, post marketing surveillance, epidemiology, retrospective/prospective, registry and bio-equivalence studies. our team comprises of an 8 member statistical and analytical practice group with a cumulative experience of 30+ person years and includes statisticians, business analysts and sas programmers to handle statistical and analytical requirements. we leverage sas 9. 2, sas enterprise guide 4. 3 andPE sas ebi to ensure full compliance to cdisc, sdtm and adam standards and have good understanding of complex techniques such as generalized estimating equation, repeated measurements, bayesian techniques, mixed modeling, adaptive trial designs, meta-analysis, etc. we work across model development, programming and validation assignments and have applied multiple tools and techniques to solving complex analytical problems including regression analysis, conjoint analysis, factor analysis, predictive analysis, discriminant analysis, multi-variate anova etc. karmic is currently developing an exhaustive set of therapeutic area wise global libraries consisting of validated macros and re-usable frameworks for enhanced programming efficiency and rapid statistical analysis

We provide an integrated solution which addresses the traditional bottlenecks in SAS Programming.Power / Sample size estimationStatistical modeling Protocol and SAP preparation Mock tables and listings Edit check programming for Data Management teamData extraction, transformation and loading to SDTM formats Analysis dataset generation Validation programming and QC Tables, Listings and Graph generation Interim analysisStatistical Analysis Integrated Summary of Safety and Efficacy Final Report generation CRT DDS and Define.xml generation Medical Writing

Bio-statistics & Statistical Programming

Statistical Programming

Statistical Programming

Statistical Programming

Biostatistics & Statistical Programming

Statistical Programming Services

Statistical Programming

Statistical Programming Languages

Statistical Programming

Statistical Programming Services