Clinical data services

CDISC Services

IQA have specialized expertise to handle CDISC data standards conversions and integrations of all sizes either for specific programs getting ready for submissions or across entire enterprise with the defined process-based conversion approach that helps us to provide high quality, on-time deliverables.

We have a set of in-house developed and validated macros which facilitate conversion of any customer specific data structure to CDISC standard datasets for both Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) with minimal work. This conversion process is well thought-out and automated to eliminate any chance of programming errors.

Our CDISC services include:

  • CDISC SDTM compliant datasets from any customer specific data structure.
  • Data conversion of legacy data to standardized data structure.
  • Up-versioning services.
  • Clinical data asset review services to support FDA submission strategy.
  • Implementation of crossover correction methods in SAS.
  • Compliance checks.
  • Sponsor Designed Standards Implementation.
  • Compliant Submission Data Packages - SDTM annotated CRF, define.xml, Reviewer's Guide.
  • Analysis ready ADaM domains, ADaM define.xml, Reviewer's Guide.
  • Validation documents and OpenCDISC Report.
  • SDTM and ADaM mapping specifications, programming and validation.
  • SDTM and ADaM transport data delivery.

Clinical Data Management

We provide end to end wide-ranging clinical data management solutions from Phase I to post-marketing trials, BA/BE studies.

Our Clinical Data Managers follow the latest technologies which provide the best solutions to the clients. We minimize the associated risks with EDC and Clinical Trial Data Management that helps capture clean and accurate clinical research data, meeting key deadlines and budget requirements.

We help our clients by reducing the cost of clinical research significantly and accelerate the drug development process. Our experts ensure that every part of the clinical research data management process is made more efficient and predictable.

Our Clinical Data Management Services include:

  • CRF/eCRF Design and Development.
  • Data Management Plan (DMP) Development.
  • Customized Database Build & Design.
  • Data processing through Double Data Entry and Comparison.
  • Data Validation and Cleansing Specifications.
  • Data Quality Check and Review.
  • CRF Annotation & Review.
  • Data Export/Transfer.
  • CDISC Compliant Mapping and Deliverables.
  • On-shore and Off-shore Clinical Data Management Services.
  • Integration with client's existing systems and processes.
  • Local Lab Data Management.
  • Database Soft & Hard Lock and Export to SAS®.
  • Data Archival and Storage.
  • Data Discrepancy Management.
  • Flexible data exports that are clean, analyzable and consistent with CDISC standards.
  • Consultation and data management strategies, systems, procedures and metrics.

Statistical Programming

Our proficient team of Statistical Programmers work closely with our experienced Biostatisticians in the creation and validation of best programming framework with set of well-defined macros and best practices. These are flexible to adapt to customer’s requirements in clinical studies from pre-clinical to post market analysis. This framework combined with our quality processes defines the “Programming Platform”.

IQA programmers have built a reputation of excellence by producing quality deliverables since many years of technical expertise in SAS®, R, WinNONLin, Data Visualization Programming combined with in-depth knowledge of specific clinical subject matter.

Services

  • Study Datasets Development - Ex. SDTM
  • Analysis Datasets Development - Ex. ADaM
  • Legacy Data conversion as per Regulatory Norms (Ex. SDTM Mapping).
  • Development of Regulatory Submission packages Ex: Reviewer’s guide, Define.xml etc.,
  • Developing TLF’s (Tables, Listings and Figures).
  • Study Analysis and Reporting.
  • Publications.
  • eCTD Submission & post Regulatory Queries Support.

We achieve the better services by abiding to the below Processes:

  • Annotated table shells.
  • Independent Validation.
  • Code reviews.
  • Centralized status tracking.
  • Strict adherence to SOPs.
  • Automates the standardized QA/QC processes.

BioStatistics

Our expert Biostatistics team adds value to client projects with extensive analysis, data-driven information, interpretation and study design. Our services are comprehensive and can be tailored to meet the needs of your specific project.

We work closely with clients throughout the life span of the project to establish methods for collecting, analyzing and presenting data while maintaining compliance with regulatory guidelines.

Services that we offer:

  • Statistical Review of Protocol and CRF.
  • Power and Sample Size Calculations.
  • Statistical Analysis Plans(SAP).
  • Randomization Schedule.
  • Development of CDISC Compliant Outputs.
  • Determine appropriate statistical techniques to answer key research questions.
  • Use modern methods to analyze complex data structures (e.g.: longitudinal data) & provide reports on statistical analyses.
  • PK/PD Analyses.

Strategic Consulting

We have expert consultants on our board who are among the leaders in the market in their respective areas. Our highly experienced consultants provide real expertise to our clients. We have wide range of consultants which enables the client to choose the one who matches their needs.

We have customized consultancy services in various clinical areas from Data Conversion, Transfer, Big Data, Open Source and Open Standards. We deliver high value consultancy services by combining our domain expertise with appropriate open source and commercial technologies.

Our consultants will be always looking to add value to whatever they are supporting and aim to help get drugs to market quicker.

We offer Statistical Consultancy in areas such as:

  • Assistance with Protocol Development and Review.
  • Biostatistics Services.
  • Program level design.
  • Statistical Methodologies to maximize Study Efficiency.
  • Ensuring study size is optimal.
  • Provide advice to researchers wishing to perform their own analyses.
  • Consultation on Study Design.
  • Study design, methodology support, education and dissemination for investigators.

Project Management

IQA offers clinical project management services to manage the BA / BE studies & clinical projects ahead of schedule. Our clinical project managing team possesses very strong technical and academic backgrounds including Clinical Trial Management, Clinical Data Management, Statistics and Statistical Programming. These qualifications accompany knowledge to proactively manage a team, from technical and administrative aspects in order to achieve quality deliverables on a timely basis.

Our approach:

  • Managing cross functional teams.
  • Addressing issues proactively.
  • Communicating closely with the Client.
  • Ensuring on-time or even early deliverables.
  • Ensuring the project remains on budget.
  • Manage team from Administrative perspective.

Our Project Leads effectively drive projects as they have a great understanding on the processes, requirements and regulatory deadlines.

We work with the mission to foresee the risks and issues and we handle situations proactively rather than reactively. Furthermore, our team has successfully governed BA/BE Studies, Clinical Study. Our team has experience in managing various types of issues and circumstances related to studies.

IQA combines your goals with our expertise to mold a strategic plan to manage projects. We govern the strategy through SOP’s and process documents to provide consistent and timely work with quality.

Service Models

Functional Service Provider

IQA offers an FSP deliverable model for clients who need additional help to run projects within their own environment. The IQA employees follow the SOPs and any process documents governed by the client, work within the client’s environment while working on the client’s projects. This can help with consistency between work and the client can manage the projects on their own terms.

Full Project Outsourcing

IQA offers an FPO deliverable model for clients that simply want a project finished with little to no oversight on the day to day operations of completing a project. A team of IQA employees are assigned to the project, follow the SOPs governed by IQA internal processes, work within IQA’s environment under their supervision. With this delivery model, clients can request a project and we fulfill the client’s requirements.