Our Planned Portfolio of Products spans the Clinical Life Cycle across Data Management, Bio Statistics, Medical Writing and Submission.
- Define R3
- Smart aCRF
- SDTM Up Versioning
- Smart CSRT
- Smart TLF Mock
What is Define XML
- Define.xml provides a navigation between the Data Definition - Information about the data, the Origin of the data and Derivation in the comment section, the Annotated CRF and the Dataset.
- The Definition of Data consists of Metadata about the Datasets that are being submitted to the FDA, Origin of the data - CRF Page number or the Derivation of the data if it is Derived. It also contains value level metadata that are possible.
- The Define.xml package includes the Data Definition File, the Annotated CRF, SAS Transport files for each domain that is included in the submission, the Reviewers'' Guide and a navigation to all the files from the Definition file with XML as back bone.
Why Define R3
- Tool saves significant time and effort in the Define XML creation process
- Effective reuse of existing/previous Study Metadata.
- Mapping and Re-Use of Metadata between CDISC Metadata & Sponsor designed standards (including metadata, IE Version, PDF Version, Controlled terminologies etc.)
- Comes preloaded with CDISC/Sponsor defined Metadata and Control Terminologies.
- Ease of upload on various versions of CDISC Metadata with Sponsor Defined Metadata for use across changes in versions.
- Easy Integration of new CDISC Metadata Standards/sponsor defined standards and Control Terminologies versions/releases.
- Facilitates Consistent and Predictable time/effort from Study Creation to Define XML.
- Facilitates Use and Re-Use of existing/previous Study and Project Metadata.
What is Annotated CRF
- This is a blank CRF document where annotations indicate location of the data with the corresponding names of the datasets and the names of those variables included in the submitted datasets.
- Each item on the CRF should be mapped to the corresponding variables in the database. It should provide the variable names and coding for each CRF item included in the data tabulation datasets.
- Annotations are meant to help the reviewer find the origin of data variables included in the submitted datasets
- Annotations should observe the guidlines prescribed by CDISC for FDA Submission of Data.
Why Smart aCRF
- Smart aCRF tool significantly reduces the manual effort of annotation using adobe acrobat.
- A Smart Annotation Repository containing the Keyword-Annotation pairing is the heart of the application. This engine learns and reduces manual effort by automatically applying annotations on a blankCRF document.
- Reverse Engineer an existing blankCRF with Annotations to augment the keyword - Annotation Repository
- The Tool allows the user to Add/Edit Keyword-Annotation pairs to the repository for repeatability of usage and application.
- Metadata - CDISC standard or Sponsor standard - can be loaded into application for usage in the Keyword-Annotation pairing.
- Progressive growth of the Annotation Repository reduces manual effort progressively.
What is SDTM UpVersioning
- Multiple SDTM IG (Implementation Guide) Versions leading to multiple study versions.
- FDA requires all Study Submissions in an NDA (New Drug Application) to be in the same SDTM IG Version
- The older versions of the SDTM should all be converted to a Single latest version of the SDTM. This is call Up-Versioning of the old SDTM Versions.
Why SDTM UpVersion Tool
- Converts Studies from Older Version to Newer/Higher Version (in a black box model)
- Pre-Loaded with Metadata for all SDTM IG Versions
- Transformation path -
- Direct Mapping
- From Supplementary Qualifiers
- New CDISC Domain
- Auto Generates Mapping Specification for Version Transformation
- Provides Input to SAS Program for Regeneration of Dataset for new version.
- Auto Generate Annotated CRF and Define for new version.
What are Clinical Study Reports (CSR)
- Clinical Study Report has to follow the structure and content of the E3 ICH Guidelines.
- Medical writers spend lot of time collating information from Protocol, SAP, TLFs and CRF.
- The objective of the tool is reduce manual effort of collating information from other sources by providing the template which will automatically collate from other existing sources.
Why Smart CSR Template
- Application will take inputs from the User (Medical Writers) with Versioning.
- Application will allow customization as per Sponsor requirements including dynamic removal and additions as sections per Sponsor/Study requirements
- Application will allow pre-population of information from Protocol, SAP, In-Text tables and CRF.
- Application will Auto generate the CSR Template as a Word Document.
What is TLF Mock Shell
- The Statistical Analysis Plan is associated with Mock Table/Listing/Figures.
- The Bio-Statistician writing the SAP typically will spend a lot of time in preparing the same.
- Even where a sample from another Study within same Compound exists, it is a time consuming task to prepare the Mock Shells in MS Word.
Why Smart TLF MOCK
- The tool will create the mock shells based on the input from the Bio-Statistician within minutes.
- The TLF numbering is based on ICH guideline.
- The tool will enforce the governance of standard mock shells.
- The tool is flexible with any therapeutic area.
- Easy to adopt a mock shell for similar studies ( Similar study design) within therapeutic area.
- Mock Shell can be standard for a company and a one time effort to configure using the tool.
SERVICES WE OFFER
All the applications we build will be lightweight, platform independent and run locally connecting to remote databases or on a server.
CLOUD HOSTED APPLICATIONS
A secure web based user interface that provides all the functionality of the Standalone applications and available on the cloud for use anytime anywhere.
We Offer CRO Services through our partner Symbiance (www.symbiance.com), who for over 25 years have been at the cornerstone of the growth of the pharmaceutical and biotechnology industry.
Symbiance is a niche provider of Clinical Data Management, Clinical Data Standardization, Bio Statistics and Medical Writing services.
Symbiance has a rich roster of clients owing to their commitment to quality and dedication.
We are a hard-core technology team with multiple years of experience in the Pharmaceutical IT industry building products of a commercial nature. The philosophy we bring to the table is – build and deliver products the Customer wants not what he/she learns to use. Our products are backed by inputs from the industry experts and our In-House SME’s and over two decades of experience in the area of clinical data analysis and regulatory submission.
Our primary goal is to bring Technology to Life Sciences SMEs and Life Sciences to Technology Experts and automate Customer needs to the highest Satisfaction.