A patient support group is constituted as a common forum or locus where patients with common diseases or interests can obtain information about their condition, share feelings and experiences and attain a sense of belonging and acceptance. Even though not being fully representative of the disease population, the pharmaceutical industry has long recognised the marketing […]
A micro-segmentation of the research enterprise along with drying up drug pipelines and piling up of un-translated basic science discoveries has prompted all the stakeholders of innovation towards development of translational medicine tools for efficacious and expedited entry of products to the market. Clinical trials are important and have lately come under scrutiny for their […]
CONSORT (Consolidated Standards of Reporting Trials) includes various initiatives formulated by the CONSORT Group to identify and rectify the effects arising from inadequate reporting of randomized controlled trials. Deficient design and reporting of randomized controlled trials is widely acknowledged and the issues are addressed in the CONSORT statement. CONSORT Statement: The main document of the […]
Systems biology can describe intricate responses to therapeutic interventions in pre-clinical studies and also provide predictive models for drug safety and efficacy before going for the clinical phases. Systems biology can potentially reduce the R&D expenditure and time by improving target identification and lead quality, better description of pharmacokinetic and toxicity profiles, as well as […]
As stated in the NIH Road map for medical research, translational research has proven to be a powerful process that drives the clinical research engine. This requires fuel (finance) to burn and a strong research infrastructure which can strengthen and accelerate this critical part of the clinical research enterprise. The Regional Development Agency, Advantage West […]
Good Clinical Practices sets the principles for drug safety information and news on adverse drug reactions, describing that the clinical study’s sponsor is answerable for the enduring safety evaluation of the novel drugs being explored. Along with this, the Good Clinical Practices must quickly inform all relevant clinicians/ethics committees and the applicable regulatory authority of […]
Contract research, a new business model, that arrived in India many years ago, has shaped itself to provide career opportunities to many individuals. Several decades ago not a single contract research organization (CRO) was operating in our nation. With the onset of globalization, privatization and the gradual recognition of India at the international stage, a number of […]
As pharmaceutical companies are looking forward to expand their territories and expand their offerings in terms of products, the trend is moving towards Biologics. This brings us to our topic of discussion of what is the basic difference between a biologic and a conventional pharmaceutical product?
A digital signature, also referred to as an electronic signature has been developed using the cryptographic techniques of verifying the originator. Using this technique, the identity of the person who uses a digital signature can be verified. The electronic system uses a complex set of rules and parameters to achieve this. A digital signature is also known […]
The Clinical Data Management (CDM) process is like clinical trials, which required a fully planned and integrated scheme from the beginning to the end. The outcome of the process is considered first and the whole process of designing the system is made by considering the final deliverable in mind. The main purpose of an effective […]