The new Vitalograph In2itive e-Diary has been certified by United BioSource Corporation for use with their EXACT questionnaire, a patient reported outcome (PRO) tool designed to standardize evaluation of COPD in international clinical trials.
One of only two United BioSource ePRO partners offering a combined spirometer and e-Diary, Vitalograph are confident that many pharma and biotech companies will now standardise on the In2itive e-Diary for their respiratory studies.
Everyone who sees the new In2itive e-Diary has been very impressed with its clear interface, not only for simple symptom scoring, medication usage and PEF/FEV1 recordings but also for validated questionnaires such as the EXACT for COPD clinical trials says Vitalograph Clinical Trials Director, Lewis Weidman.
We designed the In2itive e-Diary to meet the FDA's PRO Guidance and to exceed the documented excellent 92% subject compliance of our well-proven PEF/FEV1 Diary. We are delighted with our new e-Diary and excited about its future in clinical trials.
The pioneering In2itive e-Diary combines an integrated spirometer, featuring a removable flow head, with an easy to use touch screen. Whilst respiratory clinical trials remain the main target this versatile ePRO system, which is the first of its kind, can be customised for use in any protocol-driven clinical trial.