Clinical Data Services

Clinical Data Services

At Vita Data Sciences, we understand that the importance of clinical data assets in pharmaceutical, biotech and medical device industry. Our expert team is committed to ensuring that your clinical trial data management process: 1) fits your project needs, 2) is highly efficient, and 3) meets the highest standards of integrity and quality by complying with Good Clinical Data Management Practices (GCDMP) and Clinical Data Acquisition Standards Harmonization (CDASH) requirements. A team of highly experienced data managers will support all CDM-aspects of our project, Individual trial databases are developed according to your business requirements, data is being consequently monitored and validated prior to transfer to the formulation level.

Our core competencies in data management comes from our thorough knowledge of standards, our flexible systems, and the effective use of vividly available data management systems.

icon1Our Clinical Data Management Services Include

  • Data Management Trial Master File Set-up and Maintenance
  • CRF Design and Development
  • Clinical Database Design and Development
  • Data Cleaning
  • Data Quality Control Audits
  • Edit Check Programming, Validation and Testing
  • Medical Terminology Coding (MedDRA and WHO drug)
  • Independent QC Review
  • SAE Reconciliation
  • Query Generation and Reconciliation
  • Database Lock

Vita Data Sciences has developed a network of statisticians who are at the cutting-edge of advance statistical design and analysis, with in-depth expertise across therapeutic areas. Irrespective of where you are in the product development lifecycle and approval process, Vita Data Sciences can provide you with the strategic consulting needed in performing/optimizing the trial design and developing a statistical analysis plan which will detail the safety and efficacy analysis methods required for securing marketing approval. We also have ample experience in representing the customer at regulatory body meetings. Our Biostatistics team offers services on complex statistical issues encountered during study design or analysis. They bring expertise and insights in trial design, sample size calculations, randomization, interim analyses, developing complex statistical analysis plans (SAPs), and consulting on adaptive design. They have extensive experience in interacting with FDA and are actively collaborating with academia, industry and FDA working groups.

icon1Biostatistics Capabilities Include

  • Protocol and Statistical Analysis Plan (SAP) Development
  • Study Design, including Adaptive Designs
  • Creation of Mock Shells of Tables, Listings and Figures
  • Sample Size Calculation
  • Statistical Reports and support for Clinical Study Reports
  • Meta-analysis
  • Randomization Schedule Preparation and Implementation
  • Programming and Validation of Tables, Listings, and Figures
  • Interim Analysis and Analysis Planning
  • Pharmacokinetic/Pharmacodynamic Analysis
  • Client Representation for the FDA
  • DMC Services

Vita Data Sciences has expert SAS® programmers who tactfully and efficiently handle clinical trial data to provide outputs in accordance with industry and regulatory standards. Our team quickly adapts client specific technologies and best practices and provides insightful analysis and clinical study reports that empowers clients to draw interpretations and make well-informed decisions. A clearly laid out QC procedure helps us to deliver results on time, and with utmost quality.

icon1Statistical Programming Capabilities Include

  • Programming of Raw Datasets and Analysis Datasets
  • Programming of Tables, Listings, and Figures
  • CDISC Conversion
  • Programming support for Clinical Study Reports
  • Programming support for Data Monitoring Committee reporting
  • Programming for Integrated Summary of Safety and Efficacy (ISS/ISE)
  • Programming support for post-marketing Periodic Safety Update Reporting (PSUR)
  • Programming for Health Economics and Outcomes Research (HEOR)

Our data scientist team is highly skilled and experienced in assisting clients with clinical data standardization across all therapeutic areas in compliance with CDISC standards. They are actively involved in PhUSE industry working groups, contributing towards shaping the future of data standards. You can be hence assured that Vita Data Sciences offers up-to-date intelligence and solutions to clients looking to develop “submission-ready datasets”. Our CDISC implementations enhances efficient data analysis and reporting, including regulatory review.

Our Statistical Programming and Data Submission team is well versed in CDISC standards and have in-depth knowledge and experience in producing FDA compliant datasets and TLFs towards submission. We take an active role in CDISC initiatives to help the industry simplify and standardize data mapping, review and submission process. As such, our team has supported multiple sponsor companies to establish CDISC, SDTM and ADaM standards at a program and therapeutic area level. We have been involved with multiple successful NDA submissions to the FDA and have built solid expertise in ensuring all the clinical data deliverables from VDS are ‘submission-ready’.

icon1Regulatory Data Standards and Submission Services

  • SDTM annotation of CRF (aCRF)
  • CDISC Compliance Checks using Pinnacle 21 Validation
  • Define.xml generation
  • Reviewer’s Guides for SDTM and ADaM
  • Integrated Summaries of Safety and Efficacy (ISS/ISE) support

icon3CDISC Implementation services

  • SDTM and ADaM Implementation Consulting
  • Creation of ADaM datasets
  • Conversion of current/legacy data into SDTM datasets

Pharmacometrics is a relatively new area of clinical research that aggregates drug, disease, patient and trial information, analyzes them and build models that will augment optimized drug development and/or regulatory agency decisions. Drug models describe the relationship between exposure (or pharmacokinetics), response (or pharmacodynamics) for both desired and undesired effects, and individual patient characteristics. Vita Data Sciences offers expert consulting and services in quantitative pharmacometrics. Our clients can benefit from our team’s proficiency in the following:

icon1PK/PD modelling and simulation

  • Clinical trial simulations
  • Exposure-Response models
  • Gap analyses and planning
  • Technical report writing

icon1Model-based Drug Development

  • Translational PK/PD modeling
  • Drug-drug interaction models
  • Regulatory Agency Interactions
  • Due diligence

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Contact Us

Vita Data Sciences, a division of Softworld Inc.
281 Winter Street, Suite 100
Waltham, MA 02451

Tollfree: 877.899.1166
Telephone: 781.466.8882

Email: info@vitadatasciences.com