Zifo RnD Solutions
Zifo RnD Solutions

ACCELERATING YOUR CLINICAL INNOVATIONS

We are a premier service provider for all your eClinical, Clinical Data Management and Biostatistics services requirements. With our global experience across therapeutic areas and EDC platforms, we help you achieve shortened timelines and improved data quality by taking a lean and risk based approach catering to you and your needs.

We assure you that all your studies are managed with predictability and control, leveraging our assets and accelerators such as

We are a global organisation and can co-locate with you or work with you from one of our on-site or offshore delivery centers. We have a proprietary execution model which focuses on a system based approach towards global execution, leveraging various industry best practices & methodologies.

KEY SERVICES

  • CRF Design from Protocol
  • Study Build / Setup
  • Custom Reports Setup
  • Integrations Development
  • Study Validation
  • EDC User Qualification
  • EDC Technology Adoption Support

We specialize in study implementation across all the leading EDC platforms. With our vast experience in a variety of EDC platforms, we are well positioned to guide you on the most suitable platform fitting your needs, based on phase of the study, type of study, therapeutic area, features, helpdesk support and licensing cost.

Once the protocol is approved and you choose your preferred platform, we accelerate the study setup process to help you quickly achieve the First Patient In / Go Live milestone, using our exhaustive, reusable CRF libraries and accelerators.

EDC Platform Experience

  • ClinCapture
  • Clincase
  • Genae e-capture.net
  • Medidata Rave
  • Oracle InForm
  • PCG Viedoc
  • XClinical MARVIN

KEY SERVICES

  • Data Management Plan
  • Central Monitoring
  • Data Acquisition
  • On-going Data Review and Query Management
  • Lab Data Setup and Management
  • SAE Reconciliation
  • Medical Coding of Terms and Events
  • Database Lock

We offer comprehensive Clinical Data Management services for a variety of EDC / paper-based clinical studies. By integrating our domain, technology and regulatory expertise, we help you achieve clean study data at an optimised cost without increasing study risks.

We help global BioPharma companies successfully and confidently file their study data for FDA / Regulatory submissions, by putting patient safety at the heart of our process and wrapping it up with our therapeutic expertise.

We tailor our services to flexibly accommodate your end-to-end data management or specific / standalone needs. These services comprise an all-inclusive understanding of study objectives, clinical design issues, and quality control measures.

We leverage industry best practices & methodologies such as QbD, FMEA and RBM to bring predictability, early error detection and give access & control to your data / study.

KEY SERVICES

  • Presentation of submission ready SDTM / ADaM datasets
    • CDASH Compliant CRFs
    • Integration of Controlled Terminology
    • Open CDISC Validation
    • define.xml / define.pdf
  • Preparation of pooled dataset creation for
    • Integrated safety analysis
    • Meta data analysis
  • Data aggregation of clinical studies; Design & Development support for CDR data modeling & reporting (SDTM+)
  • Data conversion of legacy data to standardized data structure
  • SEND planning
    • Evaluation of process impact
    • Gap Analysis for SEND compliance
    • SEND data management framework
  • SEND implementation
    • Production of SEND submission package
    • Validation of SEND datasets
    • Design SEND compliant Data capture system

We convert and standardize legacy research data or on-going study data to the CDISC standards including SEND, SDTM, ADaM and sponsor specific standards. Harnessing our CDISC expertise along with our domain knowledge and regulatory requirements, we have helped global BioPharmas shorten the time taken to create "submission ready" datasets.

Our CDISC consultants provide all the required inputs to our sponsors, right from CRF design as per CDASH standards to creating submission and analysis datasets using SDTM and ADaM standards.

We help our sponsors fast track their clinical study data conversion and standardization needs by leveraging our CDISC tool kits comprising of reusable components, templates, tools and accelerators.

FDA's guidance released in December 2014, mandates electronic submission for animal data as per SEND standards. (For NDA, ANDA, and included BLA submissions: Studies starting after 12/17/2016, For included INDs: Studies starting after 12/17/2017). With a specialized in-house team of dedicated data standards experts, Zifo offers a spectrum of services that target the SEND initiative to standardize animal data.

Zifo is a CDISC Registered Solutions Provider for ADaM, CDASH, Define-XML, SDTM, Study / Trial Design Model, and Controlled Terminology Standards

TOOLS AND ACCELERATORS

CDISC Specification

  • Validated specification to accelerate SDTM / ADaM extracts
  • Ensures correctness and readiness to generate define.xml

define.xml Generator

  • Generates define.xml from the specification

Data Structure Enabler

  • Generates blank SAS datasets from define.xml which can be used for further development

Conform Structure

  • Compares the final SDTM / ADaM datasets against the define.xml
Biostatistics

KEY SERVICES

  • Statistical Inputs to Study Protocol
    • Sample Size Calculation
    • Randomization Plan
    • Statistical Considerations
  • Statistical Inputs to CRF Design and ADaM Specifications
  • Creation of Statistical Analysis Plan
  • Creation of Data Display Plan (Sample Shells for TLGs)
  • Creation of TLGs
  • Creation of Statistical Analysis Report
  • Statistical Review of Clinical Study Report
  • Biomarker Analysis (High Throughput Data)
  • Genotyping Quality Control and Analysis for GWAS

We provide biostatistics services for conducting all activities associated with data summarization, statistical analyses and reporting of the study. Our team has extensive experience in designing, analyzing and reporting clinical studies across a broad range of therapeutic areas, supported by robust processes and a global infrastructure.

Our biostatistics services include providing statistical inputs to clinical protocol and CRF design, sample size determination, creating statistical analysis plans, generating tables, listings and graphs, interpreting and reporting the results. Our biostatistics team provides consulting support during Meta-Analysis and integration of safety and efficacy analysis.

KEY AREAS INCLUDE:

  • Observational Studies
  • Bioavailability and Bioequivalence (BA / BE)
  • Phase I-III Clinical Trials
  • Post-marketing Studies
Clinical Data Analytics

We believe in reporting solutions being crucial elements of business intelligence that imparts comprehensibility and clarity to research studies. A keen understanding of end-user needs has enabled us to provide specialized services in research study analysis using a variety of reporting technologies.

Text Based Reporting

We provide customized reporting solutions developed based on the study schema either as a stand-alone implementation or as an integration with EDC products. Our reporting solutions have empowered sponsors to identify bottlenecks early in the study lifecycle and line out appropriate courses of action.

Our reporting areas are spread across, but not limited to:

  • Study Metrics
  • Patient Profiles
  • DM Reports
  • Manual Review
  • Manual Checks
Graph Based Exploration

We use data visualization tools like TIBCO Spotfire, Tableau, QlikView, SAS VA, Excel, etc. to build graphical elements. These enable visual exploration of the information behind data to build relevant stories and discover important inferences that help in making strategic decisions.

We have used data visualization cases to,

  • Achieve Operational Excellence
  • Identify Outlier Data Points
  • Build Visual Dashboards for Study Metrics / Operations
  • Develop and Render Statistical Outputs

Industry Membership and Partners

Zifo has partnered with, or is a member of select organizations recognized for their outstanding contributions to the life sciences Industry.

cdisc oracle medidata