News and Research

Key Milestones in Japan In May 2018, RealWorld EDC passed its first audit by a Japanese CRO. The following month- in June, the Company passed a Japanese pharma audit. We started our first two studies in Japan in 2018 for two of the leading Japanese pharmaceuticals companies in two therapeutic areas: Ophthalmology and Biological Medicine.

Putting the patient at the centre of treatment is a long-appreciated goal in healthcare and it describes a model where decision-making is shared between multiple stakeholders. In the past, the needs of the physician used to be the main focus of pharmaceutical marketing, while today “the customer” comprehends: doctors, nurses, non-clinical staff, and of course…

When manufacturing a new medical product, such as new drugs or therapies, pharmaceutical companies go through clinical trials to ensure that products are safe, effective and efficacious. Although these trials are heavily regulated processes, not all side effects of a drug can’t be anticipated making essential to monitor, identify and assess adverse events that did…

Medical care and biomedical research have experienced a data revolution in the past years, and RealWorld Data is deeply connected to it. Clinical trials play a critical role in reviewing the safety and efficacy of drugs and are designed to meet regulatory standards, but they often take place in highly controlled settings that may not…

White paper on cost of running NIS studies in the Cloud for Pharma..

White paper on rules to better data management and Pharmacovigilance in NIS

Collecting real world evidence in a local market is becoming increasingly important for a variety of reasons. It raises product awareness with local key opinion leaders (KOLs), gathers data to support health technology assessments, satisfies safety requirements for regulators and demonstrates the value of new medicines in the market.

CTEP’s Head of Operations Tomas O’Mahoney presented at the 2015 annual ACDM (Association of Clinical Data Management) Conference on the topic of non-interventional studies. Tomas presented his topic “Making BIG DATA smaller… Non intervention (NI) studies – 7 simple rules to better data management and 4+1 for improved pharmacovigilance in NI studies” at the industry-leading conference.

Tomás O’Mahoney, Operations Director, writes in the Association for Clinical Data Management’s journal Data Matters on “PARAs must be fit”.