CONSISTENT HIGH QUALITY & ON-TIME COMPLETION POWERED BY CLINICAL DOMAIN EXPERTISE

Why Algorics?

Our team of clinical domain experts comprises of highly experienced statisticians, programmers and metadata specialists.

Our flexible resourcing models allows us to work with wide range of customers from therapeutic specialized CROs, early stage biotech’s to top 10 biopharmaceutical companies FSP projects.

Our innovative proprietary software drives significant efficiencies in standardising & transforming clinical data.

Biostatistics Statistical Programming CDISC Services Clinical Data Management

Biostatistics

Full-service statistical consultancy for all phases of clinical trials and real-world research.
  • Statistical inputs to protocol development
  • Sample size computation
  • Generation of randomization lists
  • Creation of statistical analysis plan (SAP)
  • Interim analysis of safety and efficacy data
  • Integrated summary analysis
  • Project management
  • Cost-effective resourcing models that offer significant savings on assigned projects
  • Continuity of resources from trial design to regulatory submission
  • Ongoing management and reporting of progress on all deliveries ensuring no surprises and cost changes
  • Collaboration with internal team on DSMB / IDMC and interim analysis

To find out more about how our statistical consultants can support you, contact us here.

Statistical Programming

High quality statistical programming with consistency and scalability.
  • Study analysis and reporting
    • SDTM/ADaM/Analysis data sets
    • Tables, listings & figures (TLF’s)
    • Patient profiles
  • Analysis of safety, efficacy data for CSR, and regulatory submissions
  • Safety monitoring, interim analysis & annual report
  • Exploratory analysis
  • Integrated summary of safety and efficacy analysis (ISS/ISE)
  • Analysis for BA/BE Studies
  • Meta-analysis
Project Model FTE model (Full-Time Equivalent)
Systems used Algorics Algorics, customer or hybrid
SOPs & process Algorics SOPs Customer SOPs and process
Resources Scale based on project needs and duration Fixed resource for the contract duration
Work schedule Based on project needs with regular progress meetings Overlap with core hours of client
Scalability Highly flexible based on the volume of the project Less flexible, requires revised work orders for increase in resources
Pricing Project based – fixed bid Time and material

Reach us to support the statistical programming and resourcing needs for your clinical trials.

CDISC Services

Seamless data standards implementation and migration.
  • Gap analysis of study documents and data standards across projects
  • Development of company standards to ensure data consistency across therapeutic areas which enables pooling and ensures data is submission-ready
  • CDASH annotated case report forms (CRFs)
  • CDISC-compliant SDTM datasets for your legacy study data and the migration to submission-ready format of data from ongoing trials
  • Study data tabulation model (SDTM) annotated case report forms (CRFs)
  • Trial design, SDTM & analysis data model (ADaM) compliant data sets
  • Integration of controlled terminology (CDISC and sponsor-defined)
  • Generation of define.xml and reviewer’s guide
  • Utilization of OpenCDISC (Pinnacle 21) validator

Our expertise on clinical data standards and metadata driven approaches allow us to provide significant value add on both legacy and ongoing trials. Talk to us on how to maximize the potential of your clinical trial data.

Clinical Data Management

Our services include entire data management activities span across database design and build, data verification, handling query resolutions and data clarifications, database final lock and study archival. We assure a standardized, process-driven approach governed by strong standard operating procedures and work procedures to ensure quality output every time.

  • CRF/eCRF design and development
  • CRF annotation & review
  • Database build & design
  • Electronic trial management support – Trial setup and management
  • Data validation specifications
  • Edit checks programming & testing
  • Data processing through double data entry
  • Query management
  • Certified Medidata RAVE Programmers
  • Access to other EDC solutions
  • Data management plan (DMP) development
  • Data management project management
  • Data export/transfer
  • CDISC/SDTM compliant deliverables
  • Real-time data viewing and reporting

We work hand in hand with our clients on a partnership model and help them achieve the targets with quality, efficiency and integrity. Our dedicated clinical data manager will work with you and team to frame out specific requirement and will follow a transparent communication channel to ensure robust productivity.