Traditionally, clinical trials are paper-based. Patients use written responses to questions and track their daily medical experiences in a written diary. Beyond the awkwardness and inconvenience, when it comes time to aggregate results from all patients to assess results, the manual process of data assembly is time-consuming and prone to errors.
Salix believed there had to be a better way and had several prerequisites for a solution to streamline the clinical trial process.
- Make trial participation more convenient for patients. Hand-written notes and responses are atypical of the way people now interact with data.
- Protect patient privacy. Adherence to HIPPA regulations and personal privacy are primary concerns for Salix.
- Make results as accurate as possible. It’s difficult to standardize response formats with paper, and there could be more accuracy if all patients could have a standardized format.
- Easily aggregate and crunch data. The faster data is in a presentable, accurate form, the quicker the approval process can move along.
That's a long wish list that seems to mesh with the capabilities of some kind of mobile device. But complicating any decision is the daunting reality that many trials include hundreds, or even thousands, of patients dispersed around the world. The intricacies of deploying mobile devices globally to be used in such a complex undertaking were more than most companies had the expertise to master.
Salix contacted Vox Mobile who began with extensive consultations to understand the unique requirements of clinical trials. Recommendations that were implemented:
- Standardization on iPad Mini. For a totally identical look and feel to the tracking application (Patient Cloud was chosen), the devices needed to all be the same model. Patients were loaned the iPad and instructed on how to use the application and participate in the trial.
- Privacy and security assurance. Patients are not tracked by name, but rather, an identification number. To further protect sensitive information, strict policy procedures were implemented to protect the devices.
For most organizations, the next part could be the factor that quashes the project in its tracks. Salix clinical trials are often global. Devices would need to conform and comply with local regulations, service levels, and language. The devices would also require the same security and management as those based domestically. However, for some companies, even the seemingly simple task of shipping a device to an overseas destination is problematic. Salix selected Vox because:
- Vox Mobile has global capabilities. Vox has a network of mobility experts and services that can deploy and manage mobile devices globally. This system accounts for the varying customs and facilities inherent in countries across all continents.
- The Global Enterprise Mobility AG (GEMA) is a joint venture founded by Vox Mobile providing enterprise mobility managed services for multinational organizations. Made up of a group of the world’s leading enterprise mobility service organizations, GEMA offers global services through in-country experts with local language and time zone services for the deployment, support, and management of the global mobile workforce.
Salix now relies on iPad Minis managed by Vox Mobile globally to gather and process data from clinical trials.
- Patients have a convenient way to track activities. Key in any clinical study is the completeness and consistency of responses. Entering information on mobile devices is a familiar, easy way to manage data, and full participation is much more likely.
- Gathered data is more accurate. By using a standardized application on the same model device globally, all patients interact similarly, and the likelihood of confusion and erroneous entries is diminished.
- Processing gathered data is faster. Aggregating data for internal analysis and for submission to the FDA is quicker and can speed the approval process.
About Salix Pharmaceuticals: Salix Pharmaceuticals is located in Raleigh, NC, near Research Triangle Park (RTP) — a world-renowned center for cutting-edge pharmaceutical research and development. Salix is committed to being the leading US specialty pharmaceutical company licensing, developing, and marketing innovative products to healthcare professionals to treat gastrointestinal disorders in patients.
iPad is a trademark of Apple Inc., registered in the U.S. and other countries