MediciGlobal launches latest version of ADapt patient recruitment system

CROs and Pharmaceutical companies are speeding the process of study launch and accelerating patient recruitment. Such initiatives involve the adoption of new processes, technologies and organisational structure. One such initiative is MediciGlobal's unique and proprietary web-based system called ADapt, focused on launching patient recruitment programmes faster. Over the past year, with the use of ADapt, global patient recruitment programmes are launching 4-6 weeks sooner in each country.

Since its introduction and beta testing with a major global Pharma company in early 2008, ADapt has had over 235 secure users creating over 2400 translations and cultural adaptations. In each case significant time and cost efficiencies have been achieved. In 2008, the ADapt system was recognised by BIO IT for its contribution to accelerating clinical development processes.

ADapt is an innovative web-based system that allows patient materials for clinical trial recruitment and retention to be rapidly customised by language, cultural and linguistic nuances, and regulations for any country around the world. Global users of ADapt are able to view approved materials, translate them into multiple languages, linguistically adapt them, and initiate the Ethics (IRB) submission process within days, compared to traditional methods of translation and design that can take weeks or months, giving physicians and study coordinators patient recruitment support sooner.

As a Functional Service Provider (FSP), MediciGlobal is making ADapt available to sponsor's to use with their own recruitment specialists, as part of their clinical trial portals, and graphic design team. "We ensured that ADapt could provide sponsors the ability to "plug and play" and incorporate it in their own clinical trial management platform," says Liz Moench, MediciGlobal's President & CEO.

ADapt combines speed with localisation by allowing those with authorised passwords; clinical teams, study staff and even research sites at the country levels to get directly involved in localising materials, together with certified translators, without delaying the process. "The power of this system is that we're pushing patient recruitment down to the local level and achieving this faster than conventional methods. ADapt brings speed, quality, localisation, and local team buy-in, and all this is achieved more cost effectively," adds Moench. "In a competitive clinical trial environment speed and customization are important. It's about getting to market faster with tools that are right for that country and study site."

The latest version of ADapt operates faster due to core architecture optimisation, and provides study sponsors and study sites with paperless Ethics submission and approval tracking. Furthermore, for auditing purposes Ethics approval letters and other documentation are uploaded into a centralised repository for 24/7 global access to authorised users, an important feature in an environment of increasing regulatory oversight.

The enhanced management features of ADapt include:

• Increased project communications between users in the field (CRAs, site staff, translators, recruitment specialists) and study sponsors
• More detailed tracking of materials in development, by country, language and specific editorial changes right down to each specific document
• Increased sponsor management of the project's overall development process
• User activity management to ensure tasks are completed and project timelines are kept on track

Global patient recruitment and retention programmes must be designed for inherent flexibility to accommodate each country's regulatory guidelines and the requirements of each research centre. Patient recruitment materials must also be adapted to reflect the nuances of different country's healthcare systems, and all materials must conform to a Life Sciences company's regulatory, legal and compliance rulings. Importantly, ADapt provides detailed real-time tracking of document changes and version control.

According to Martin Collyer, MediciGlobal's Chief Operating Officer, "ADapt is a key advance in accelerating patient recruitment and retention and providing study sponsors and sites more management and control over the development of recruitment materials."