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