IntegraIT

Clinical trials in countries where research sites are few, languages vary and participants are hard to keep engaged need software that was designed with those conditions in mind. IntegraIT builds cloud tools for planning, running and monitoring such studies. It says it has worked since 2009 in 17 countries and across 17 therapeutic areas, including vaccine trials.

The software it sells

The company describes a software as a service ecosystem for every phase of clinical research, usable whatever the size of the study. The named products are:

• Study Tracking System, which schedules and records visits to research sites and tracks what follows from them, for a single trial or many at once.
• TrialPal, an electronic patient reported outcome and clinical outcome assessment tool. It supplies electronic diaries and monitoring forms that can be used for active or passive surveillance, so sponsors see participant data as it comes in.
• Tools that pass information from one study system to another.
• Dashboards that give a live view of a clinical trial, real-world evidence work or an observational study, so that sponsors can follow key performance indicators and make decisions as results arrive.

Why emerging markets are the focus

IntegraIT says its mission is to widen clinical research possibilities worldwide, especially in diversity, inclusion and emerging countries. Experience in those markets, it says, has taught it how to increase patient engagement, keep adherence high and reduce drop-outs by understanding people's culture, context, technology literacy and language. The site presents knowing the patient as the way to do the job well.

Standards and quality

The firm states that data privacy and quality come first, and it cites ICH good clinical practice, 21 CFR Part 11, GDPR, EU Annex 11, the ALCOA data integrity principles and HIPAA as the rules its solutions are built to respect. It also reports that its work has passed US Food and Drug Administration inspections with satisfactory results.

Who uses it

The intended customers are drug companies, contract research organizations and the sites that carry out studies, from the first human trials through post-approval research. The company says its mix of agile software engineering and clinical operations expertise lets it deploy quickly, and that its flexible, scalable tools give end-to-end control and visibility of a trial.