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14May 2018

Drug development is a challenging and time-consuming procedure. An unmet medical need is a condition, the cure or diagnosis of which is not being addressed effectively by currently available therapies. To meet such an unmet medical need and treat severe diseases, Fast Track approval process has been introduced by Food and Drug Administration (FDA), which […]

06May 2018

The most recent evidence shows patient recruitment and retention issues to be a persistent problem in clinical trials. Also, it is almost certain that this problem will only continue to grow as the years go on. (1,2) Missing data is often due to patients being lost to follow-up or withdrawing before data collection time points, […]

24Apr 2018

There is heaps-full of data existing in the healthcare domain that has been generated historically, by means of record keeping, compliance & regulatory requirements, and patient care. (1) The current trend suggests faster digitization of this large amount of data, known as ‘Big Data’, that have been stored as hard copies over time. Big Data […]

09Apr 2018

Currently, the data protection law in India is facing many issues due to the absence of proper legislative framework. The theft and sale of stolen data is happening across vast continents, where physical boundaries pose no restriction in today’s technologically advanced era. India, being the largest host of outsourced data processing in the world, could […]

03Apr 2018

Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, […]

29Mar 2018

Every country exercises strict control on medicines’ market access. Typically, this requires successful completion and adequate presentation of results from phase I through phase III clinical trials, bringing forward the findings of medicine’s safety and efficacy. The USFDA approves approximately 40 new medicines for the US market each year through this process. (1) In India, […]

21Mar 2018

Healthcare outcomes are defined as the changes observed and/or recorded in health status of individual or population patient/s usually due to an intervention, measures or specific healthcare investment. (1) The goal is to save the lives, shorten hospital stays and build healthier communities relying on preventative measures. (2) The fundamental steps of improving outcomes are […]

14Mar 2018

Patient Records Abstraction (PRA) is a process done manually by searching through a medical record to identify data required for a particular or secondary use. It consists of direct matching of information found in the record to the data required, but also includes operations on the data such as categorizing, coding, transforming, interpreting, summarizing, and calculating. The […]