Clinical & scientific operations case studies

Maximising patient recruitment and retention, and expanding access to diverse patient populations.

We work with you to develop strategic, flexible approaches that leverage clinical informatics, state-of-the-art technologies, and our global reach to make data-driven decisions for every study.

Effective collaboration on clinical data standards governance

91��'s Global Data Standards team helped a large pharmaceutical company consolidate multiple standards libraries into a single, harmonized library used across therapeutic areas.

91�� implements new Lay Protocol Synopsis (LPS) program

Increased trial transparency has been a growing industry trend for many years. The largest recent initiative in this realm
is the European Medicines Agency��s (EMA��s) Clinical Trials Information System (CTIS), which went online in January
2022.

IRT User Acceptance Testing

Resolving critical issues and ensuring trial integrity

Evolving quality oversight to limit sponsor burden

91�� implemented a Data Management Asset Lead (DMAL) role to provide oversight and ensure adherence to standards for a sponsor with limited bandwidth.

Applying statistical and programming expertise to overcome FDA challenges

91�� supported a biotech company in preparing for FDA submission by quickly mobilising a team to address unexpected comments on statistical analysis and data collection, resulting in timely BLA submission, enhanced data quality, and alignment with FDA requirements.

The importance of CRF design in cell and gene therapy studies

91�� partnered with a biotech sponsor to optimise Case Report Forms (CRFs) for an oncology cell and gene therapy trial. By adopting iRECIST criteria and standardising CRF templates, we reduced data duplication, ensured accuracy, and provided flexibility for subject re-treatment.

CRF design for a cell-therapy, immuno-oncology study

91�� developed flexible, cost-effective CRF designs for a cell therapy immuno-oncology study, harmonising RECIST and iRECIST criteria while addressing re-treatment requirements and supporting sponsors in meeting study timelines.

Optimised adaptive trial design for oncology biotech

91�� assisted a US-based oncology biotech in overcoming timeline, data uncertainty, budget constraints, and pressure for publishable results by offering a cost-effective phase 3 trial design with interim analysis, enabling early efficacy and regulatory approval with minimal upfront investment.