Filter By

Achieving an Aggressive NDA Timeline

Imagine you are completing your regulatory submission project with only nine months left until submission day and you still have to migrate legacy data into SDTM format for 18 studies as well as 2 ongoing pivotal studies. 

Case Study

Data Collection Efficiency for a Novel Anti-Infective Therapy

Learn how we improved data collection efficiency through thoughtful database design that allowed the sponsor to overcome a complex trial challenge and transition smoothly from Phase II to Phase III.

Case Study

Exceeding Expectations For Patient Enrollment Case Study

When Veristat partnered with a US based biotechnology company on a Phase II study for a topical spray to treat hypertension, our emphasis on effective planning and management led to overwhelming success.

Case Study

Guiding an Oncology Program to Success

A clinical stage biotech firm engaged Veristat to run their very first ever clinical trial, a phase I US only oncology trial. When the project started, the client was a three-person team. Veristat was and still is the entire project team and we have and continue to work with this client to guide them and train them through the clinical trial process.

Case Study

Keeping Up with an Over-Performing Site Case Study

Find out how Veristat was able to expertly rescue the site management and monitoring activities for a  sponsor seven months into patient enrollment at the site by utilizing our adaptable project managers and monitoring services.

Case Study

Medical Writing Partnership - IND to NDA

Learn how the Veristat medical writing team partnered with a sponsor and supported their entire rare oncology program from IND to NDA.

Case Study

Preparing a New Drug Application (IND)

Veristat has collaborated with biopharmaceutical firms on the preparation of over 50 INDs. Learn how we successfully helped a sponsor finalize their IND in under 6 weeks.

Case Study

Preparing Data for a Marketing Authorization Application (MAA)

Read the case study to learn how we helped a biotech prepare the MAA submission for a recently acquired product. Our creative approach included utilizing one DB for three studies and standardizing data by study instead of domain.

Case Study

Quick Feasibility Assessment to Expand Trial Into Europe Case Study

Veristat provides a feasibility assessment to a clinical stage biotechnology firm who wants to know whether it is feasible  to expand their current US study into European sites. Being an oncology study, the trial had some very specific technology requirements for the site and part of the assessment was to determine if that technology was available at sites in Europe

Case Study