The need for ‘Real World’ data
In order to leverage the value of their products the pharmaceutical industry recognises the need to dramatically improve the collection of ‘Real World’ data. Find out more.
In particular the collection of Patient Reported Outcomes (PROs) must play a pivotal role, particular those describing health related quality of life (HRQoL).
The collection of Real World data from clinical practice is not straightforward. Any electronic data capture (EDC) systems operating in the real world must have a minimal burden on clinicians and patients and be easily integrated into existing clinical practice. Current EDC platforms carry the legacy of regulatory requirements and are therefore not well suited to real world applications.
PhaseIV - flexible EDC for the Real World
Our goal at Pharmatelligence is to produce a new EDC platform better able to cope with the demands of collecting data in the ‘Real World’.
Our platform, PhaseIV, is based on the same document database architecture as used by social networking media. This considerably reduces the ‘back-end’ support requirement associated with traditional relational databases. This allows the system to respond far more flexibly to individual user-needs rather than the user feeling constrained by the needs of the system. It also is more easily integrated with emerging web-standards such as HTML5.
Our user-interface designers have created intuitive ‘front-end’ tools that require minimal user training with a look and feel close to that of paper-based data collection methods.
For users bound to paper-based processes we have also integrated a digital pen data capture system. This allows users to work with their existing proforma but instantly translate handwriting and pen-strokes into usable data. The pencasts are then immediately available for remote source document verification (SDV).
Ongoing developments scheduled for release in Q3 & Q4 2011 include flexible scheduling and data-monitoring tools to guarantee the quality of received data, and implementation of dynamic reporting tools.
Pharmatelligence have a major pharma client implementing PhaseIV as the EDC platform for a multinational post-marketing non-interventional study, recruitment commencing Q4 2011.