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Clinical Trial Study Standardization Service
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Biostatistics & Statistical Programming

TransGene provides biostatistics & statistical programming services to its clients in the entire clinical development cycle – protocol development, study design, statistical analysis, and regulatory submission. Trained and competent professionals at TransGene have great eyes for details to provide insightful analysis and reporting of clinical study data that enables clients to draw inferences and make well-informed decisions.

Our focus is to add value to the clients with our expertise in standard statistical reporting tools and systems. Our team is dedicated to providing services in compliance with current industry standards and regulatory guidelines. 21CFR-Part11 compliant systems and well documented SOPs are the back-bone for project implementation. We are up-to-date with evolving industry standards, changes in the regulatory environment and enhancements in technology and applications.

The wide repertoires of projects we have delivered in multiple therapeutic areas across the drug development lifecycle. Our focus on automation and process optimization, combined with the ability to customize solutions that are tailored for client-specific environments, make us a trusted partner with pharmaceutical companies and CROs to deliver high quality analysis results.

With global presence and team of expert biostatisticians and SAS programmers, TransGene is uniquely positioned to provide a wide range of biostatistics and statistical programming services to our clients in a space where timely delivery and accuracy is of paramount importance.

Our Services Include :

  • • Statistical Input to Protocol/Study Design Development.
  • • Sample Size Estimation.
  • • Randomization Schedule.
  • • Review of CRF and Data Management Plan.
  • • Statistical Analysis Plan (SAP) and Mock-up Shells.

  • • Analysis of Safety, Efficacy Data for CSR and Regulatory submissions.
  • • SAS Programming – SDTM(Study Data Tabulation Model) /
    ADaM (Analysis Dataset Model) Datasets and Tables, Listings, Figures.
  • • Design and Deployment of System-level SAS Macros.
  • • PK/PD Analysis.
  • • Integrated Safety and Efficacy Analysis (ISS/ISE).
  • • Analysis for BA/BE Studies, Meta Analysis.
  • • CDISC Implementation Service.
  • • Support Safety Monitoring, Interim and Exploratory Analysis, Manuscripts and Abstracts.
  • • Patient Profiles/Safety Narrative.
  • • Statistical Report Writing.

Clinical Data Interchange Standard Consortium (CDISC)

Building on the advantages of standardization, the Clinical Data Interchange Standards Consortium (CDISC) has provided extensive guidelines for the collection, analysis and submission of clinical trial data for regulatory compliance purposes. Today CDISC standards are widely accepted by the industry and regulatory agencies, therefore necessitating the need of conversion of existing data into CDISC standards.

Our thorough understanding of CDISC standards, superior statistical programming capabilities and integrated tools and processes enable us to deliver CDISC compliant deliverables with greater
efficiency.

Our CDISC Services :

  • • Conversion of Legacy raw data into SDTM datasets.
  • • Compliant Submisson Data Packages – SDTM annotated CRF, define.xml.
  • • Analysis ready ADaM domains, ADaM define.xml.
  • • Validation documents and OpenCDISC Report.
  • • Reviewer's Guide.
  • • SDTM(Study Data Tabulation Model) /ADaM (Analysis Dataset Model)Compliant Integrated Databases.

    • We follow a three-branched approach to deliver high quality CDISC services to our clients :

    Process

  • • Established procedures, work instructions and checklists.
  • • Defined workflow to generate SDTM (Study Data Tabulation Model) and ADaM (Analysis Dataset Model) standard data packages.
  • • Validation and verification strategy to ensure integrity and accuracy of deliverables.
  • • Project management to ensure smooth project execution.

    • People

  • • Expert programmers with prior domain experience.
  • • Exposure of implementing CDISC standards in diverse therapeutic areas.
  • • Emphasis on continuous learning and training to remain abreast with latest standards.

    • Tools

  • • Use of latest technology framework like Pinacle21 Validator to ensure adherence to standards.
  • • In-house Macro library with pools of SAS macros and utilities to achieve efficiency in conversion process.
  • • Automated system to generate Define.XML.

    • TECHNOLOGY SOLUTIONS

    Healthcare industry has made significant progress in the last decade due to advances in computing technologies and cloud digitalization. The ability to gather real world evidence and analyse this data has changed the world of healthcare.

    TransGene, a healthcare analytics company provides technology services with a focus of adding value to customers in an industry with evolving standards and periodic changes in the regulated environment. We operate in a world with evolving customer needs to meet changes in customer specific requirements.

    An advancing world under constant technology transformation creates new application possibilities giving opportunities to focus on automation and process optimization, combined with the ability to customize solutions that are tailored for customer-specific environments. We have vast expertise in leading edge technologies making us a trusted partner to deliver technology solutions for diagnostic, predictive and prescriptive analytics in the ever-expanding regulatory domain of healthcare.

    A major technological breakthrough has been web-based applications hosted on the cloud. The cloud applications share information easily, improves operational efficiency, provides high data security at optimal costs. The cloud and virtualization technologies have potential to provide clinical trial sponsors, CROs and healthcare service providers an incredible opportunity to improve services to their end customers.

    TransGene is well poised to utilise the cloud benefits for its customers’ advantage. Our services include technology services and solutions to clients in the entire gamut of healthcare analytics. The wide spectrum of data driven projects delivered by us, span multiple web-based technologies hosted on the private and public cloud.

    Our technology development team supports and acts as extension to customers, product development initiatives in the clinical and healthcare domain. All services delivered at TrasGene ensures high level of data protection that meets the rigorous industry standards. Agile methodologies in product development and risk management practice in the company facilitates our endeavour to achieve service excellence. The company is in process of ISO accreditation and our processes include change control and compliance with regulations such as US 21 CFR Part 11 and EU Annex 11.

    CLINICAL DATA MANAGEMENT

    Capturing quality clinical trial data is the key to ensuring patient safety and confirming efficacy in clinical development today.

    We provide data management services from study start-up to database lock within mutually agreed timelines, also ensuring data quality and integrity. Our CDM team guided by standard procedures, will analyse the data collection requirements from clients, implement different effective strategies, and thereby provides the best solution in a quick, reliable, and cost-effective manner. The team has rich experience in handling various industry benchmark EDC tools to design and review Case Report Form (CRF), visualization and reporting tools such Spotfire and J-Review.

    Our expertise sways beyond traditional CDM services and our capabilities include risk-based monitoring, medical coding and automation across therapeutic areas including vaccines and experience in managing various phases of a clinical trial.

    Our project management capabilities have been our strength with risk management experience, robust communication framework, enhanced data security and business continuity readiness, people friendly culture all leading to achieve our goal of exceeding customer expectations.

    EXPLORE OUR CLINICAL DATA MANAGEMENT SERVICES :

  • • Consulting (strategic program planning, protocol review, EDC selection, etc.
  • • Protocol design and review.
  • • Case Report Form (CRF) design utilizing the current CDASH and SDTM standard.
  • • Database setup / design, validation, and maintenance.
  • • Data validation programming and testing, inclusive of derivations, edit checks, custom functions, and manual review listings.
  • • Coding of diagnoses, AEs, and drugs.
  • • Local laboratory administration with the EDC systems.
  • • Database lock and archiving.
  • • Data transfer and integration.
  • • Data visualization and reporting.
  • • Overall study management.

    • REAL WORLD EVIDENCE

    RWE with TransGene

    TransGene provides Real World Evidence (RWE) analytics services to bridge the gap between Randomized Controlled Trial (RCT) information and
    Real-World Data (RWD) helping clients achieve patient-centricity.

    What are RWD & RWE ?

    RWD is any patient data collected after Randomized Clinical Trials have been completed and have led to adoption of treatment in the real world. Such observational data are needed to address payor and regulatory pressure to demonstrate the value, safety and effectiveness of approved products in a real world setting. Real World Evidence (RWE) is based on insights generated through analytics on RWD. The outlook for RWE is seen as promising as it offers the potential to improve health outcomes and the cost-effectiveness of new treatments.

    Data Sources

    Before Electronic Health Report (HER) data was available, Companies and healthcare organizations relied on claims data and chart audits to help them understand how their products were performing in the real world. With the prevalence of EHR data, we are now able to effectively analyse RWD to generate RWE.

    Real world information is typically obtained from,

  • 1. Medical records (Charts & EHR).
  • 2. Claims
  • 3. Hospital
  • 4. Payor
  • 5. Economic

    • Together these data sources can provide a view of the healthcare ecosystem to help with the new drug discovery process and to measure the effectiveness of existing treatments.

    Challenges

  • 1. Low quality data and lack of content.
  • 2. Common standards not established yet for RWD
  • 3. Methods for analysing and linking data is limited
  • 4. Lack of ways to measure the impact of RWE
  • 5. No governance for data governance and data sharing
  • 6. Concerns over privacy and data protection

    • How does TransGene help with RWE ?

    TransGene helps Companies address data analysis and linking (challenge 3) and impact measurement (challenge 4) for RWE with data protection and security (challenge 6).

    Our approach to RWD & RWE is based on our deep expertise with patient data that includes clinical, EMR/EHR, hospital and lab data. We leverage this expertise to.

  • • Bridge the gap between RCT (Randomized Clinical Trials) information and observational patient experience.
  • • Generate deep insights for funding allocation, product performance in a competitive context, identifying new MD and patient targets.
  • • Understand the impact of value based systems that are becoming more relevant.

    • TransGene built its data infrastructure, protection and privacy capabilities to handle both clinical data and real-world data.

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