“I have said time and again, but you have been so helpful and your data has been by far the ‘smoothest’ of all our vendors. Thank you so much for being so proactive. I would recommend you in a heartbeat,†declared Sam Blackburn, lead Data Manager for a Top 10 Global Pharma and sponsor of the record-breaking trial upon locking of the database.
Nearly half a million data points were collected across 145 centers and 28 different languages in one of the largest implementations of writeresult’s unique digital writing ePRO solution to date. The project utilized both disease-specific and general Quality of Life (QoL) instruments to assess response to treatment of just about 1000 patients with moderate to severe chronic-plaque type Psoriasis. The Phase III clinical trial began collecting data from its first patient in August 2011. "This study database lock represents a significant milestone for data management at writeresult; delivering this volume of data on-time and to our high quality standards demonstrates the scalability of our data management processes and project management," explained Amani Kitali, MPH PMP.
writeresult utilizes a matrixed team management approach to trial execution drawing from its expertise in Clinical Operations, Clinical Data Management and Project Management to ensure projects are delivered on time from study start-up through database lock and close-out. This integrated approach means that time and time again, a client’s needs to execute to tight timelines can be met. In fact, a database lock has never been held up because of writeresult’s data in more than half a decade that they’ve been executing trials. “We are part of that study team. We are accountable to our colleagues around the world for the success of the study, and we feel a responsibility every day to the patients who are sharing their feelings in every page we review. We also have a great record of achievement so far-- we don’t want to ruin it!†smiles Director of Electronic Clinical Data Systems Ellen Goldberg.
For more information on writeresult’s ePRO solutions, contact Karen Briegs at (908) 272-4787.
Nearly half a million data points were collected across 145 centers and 28 different languages in one of the largest implementations of writeresult’s unique digital writing ePRO solution to date. The project utilized both disease-specific and general Quality of Life (QoL) instruments to assess response to treatment of just about 1000 patients with moderate to severe chronic-plaque type Psoriasis. The Phase III clinical trial began collecting data from its first patient in August 2011. "This study database lock represents a significant milestone for data management at writeresult; delivering this volume of data on-time and to our high quality standards demonstrates the scalability of our data management processes and project management," explained Amani Kitali, MPH PMP.
writeresult utilizes a matrixed team management approach to trial execution drawing from its expertise in Clinical Operations, Clinical Data Management and Project Management to ensure projects are delivered on time from study start-up through database lock and close-out. This integrated approach means that time and time again, a client’s needs to execute to tight timelines can be met. In fact, a database lock has never been held up because of writeresult’s data in more than half a decade that they’ve been executing trials. “We are part of that study team. We are accountable to our colleagues around the world for the success of the study, and we feel a responsibility every day to the patients who are sharing their feelings in every page we review. We also have a great record of achievement so far-- we don’t want to ruin it!†smiles Director of Electronic Clinical Data Systems Ellen Goldberg.
For more information on writeresult’s ePRO solutions, contact Karen Briegs at (908) 272-4787.