Chh. Sambhajinagar (MH), India  ·  New Jersey, USA  ·  Toronto, Canada contact@sumptuous-ds.in Mon to Fri, 9:00 AM to 5:00 PM IST
Home / Case Studies

Case Studies

Real problems we have solved across therapeutic areas and regulatory settings.

Case 01Sickle Cell Disease

Data Operations for Sickle Cell Disease Trials

Problem

Drug trials and pooled data analysis requiring complex dosing algorithms due to acute pain-driven treatment nature.

Solution

Our biostatistics team analyzed pain instances and ensured the correct dosing algorithm was applied alongside appropriate clinical data representation.

Outcome

Successful submission of trials and pooled data to regulatory bodies.

Case 02Microbiology

Microbiological Endpoints in Superbug Disease

Problem

Complexities with microbiological data including collection issues, tricky baseline/endpoint definitions, and missing information.

Solution

Working closely with study microbiologists to determine robust baseline definitions and handle missing data through indirect endpoints.

Outcome

Successful determination of microbiological endpoints and improved collection requirements.

Case 03Immunology

Lupus Disease Regulatory Submission

Problem

Significant missing data, difficult efficacy analysis with multiple regulatory queries, and complex dictionary term versioning.

Solution

In-depth disease domain knowledge was critical. The team processed data per precise business requirements extensively.

Outcome

Successful regulatory submission with drug safety report and risk management plan.

Case 04Oncology

Sample Size Estimation — First-in-Human Study

Problem

Sample size and RP2D determination for a Phase I/IIa oncology study with a limited patient population.

Solution

BOIN12 model for safety/efficacy-based RP2D determination; Simon's 2-stage model for Phase IIa sample sizing.

Outcome

Sample size determined from operating characteristics for proposed toxicity-efficacy models.

Let's talk about your data

Whether you need a team for your next study or a partner for a health data programme, we'd be glad to hear from you.