Clinical data management services are regaining significance in the CRO industry. The industry which started in the US during 1970s primarily offered data management services to pharmaceuticals and bio-pharmaceuticals industries. Later these CROs started taking up clinical research services, and now again, data management services have picked up attention by several CROs across the world and in the US. Several voluntary groups in the US are helping the industry with necessary training in data management.
Big pharmaceuticals companies and small and medium size bio-pharmaceutical companies are actively seeking outsourcing partners in the data management segment. India with its low cost advantage has potential to be a hub for such outsourcing activity. US companies, both manufacturers and CROs, will seek partnerships with their counterparts for these services to reduce costs.
Dr Carolyn E Rugloski, senior director, Business Development, i3 StatProbe, said, Electronic Common Technical Document (eCTD) has been one of the major achievements that has changed the scenario in regulatory submissions. There have been several improvements in the way the data has been managed. It has been emphasised always that data should be accurate and reflect the source. Self-regulation is still the only way to maintain quality in data management.
Several countries are creating national clinical trials registries as they address the needs of vast audience. These registries are proved useful to not only the medical community but also the subjects. Paperless data management is the current trend and the US government is constantly stressing on it. Electronic data capture is the best advancement so far in this field, she added.
The Data Safety Monitoring Boards worldwide are giving priority to protection of human subjects. The Food and Drug Administration (FDA) has framed clear guidelines for Data Monitoring Committees (DMCs) and Data safety Monitoring Boards (DSMBs). FDA regulations and ICH guidelines are ensuring uniform standards in data management, globally.
The sponsor-CRO realignment has increased the speed and efficiency of drug development efforts while maintaining clinical trial-data quality and high levels of regulatory compliance, as per a Tufts Centre for Study Development Report.
According to the US-based Association of Clinical Research Organisations (ACRO), clinical projects that relied heavily on CRO participation submitted their data to regulators more than 30 days closer to the projected submission date than projects with less CRO participation.