Recently MakroCare has been selected by a growing US biotech company to support a registry program to create around 1500 cancer patients data. MakroCare specialized in RWE and outcomes research has been engaged to offer services for protocol design/writing, data collection, data monitoring, analysis, study reports and manuscript preparation for this registry. MakroCare will also be providing a customized, user- friendly data collection tool (mEDC) (from its tech division-DDi) to collect the patients data from over 100 investigational sites. To facilitate this registry program, MakroCare will be working with the sponsor to design, launch and maintain a website for the registered investigators to keep them updated with published data, news & notifications throughout this program.
The objective of this registry is to collect real world data focusing on treatment decision impact, outcomes in the management of cancer patients and clinical utilization of the diagnostic platform in various cancer patients. This retrospective & prospective, multicenter, non-randomized, single arm, real-world data collection registry is expected to enroll around 1500 patients over the period of 5 years. MakroCare will also be supporting the sponsor with the interim data analysis annually which will be cumulative in nature. Some of the key outcomes of this registry would be clinical utilization pattern, treatment-decision impact, clinical benefits rate and objective response rate.
As RWE and outcomes research are becoming increasingly important and necessary for product development and commercialization, MakroCare is well equipped to offer technology integrated, cost efficient, non-traditional solution to support biopharmaceutical companies in this space.