THE RKM - EDGE

The current number of trials registered in the Clinical Trial Registry of INDIA (www.ctri.nic.in) is soon going to reach 50,000 – this is an outstanding number for any country in the CR Industry. As the nation’s healthcare prospects increase, this number is only going to go higher in the days to come.

Though INDIA is emerging as a global leader, still there are certain areas of concern when it comes to Clinical Research – a primary concern is related to quality documentation – as the CR adage goes – ‘If it is not documented, then it did not happen.’ RKM-CR has studied this concern from various perspectives and has come up with an effective CAPA plan to ensure the quality is not compromised at any stage.

The next important concern is related to speedy Patient Recruitment – RKM-CR understands that the CRO/Sponsor are always on the lookout to complete recruiting the required number of patients as defined in the Protocol at the earliest. Every day is MONEY – yes, we know it well enough and acknowledge it. This is the sole reason that our team has come up with some innovative strategies that we constantly improvise to ensure the recruitment happens at a quick pace.

The third important concern is related to patient retention and follow-up. CROs and Sponsors often dread the terms: ‘Patient Drop-Out’ and ‘Patient Loss-to-follow up’. Retaining the patients for the entire study duration plays an important role to ensure statistical efficacy of the investigational product. Many investigators are either too busy or too complacent and do not understand the importance of patient follow-ups as per the Protocol specified timelines. This is where RKM-CR comes in with astutely trained CRCs Clinical Research Professionals who will ensure patient follow up at a higher degree and minimize the number of patients dropping out of the clinical trial.

CLINICAL RESEARCH – A GENERAL OVERVIEW

What is Clinical Research? Many people are still not fully aware of this concept. Well, we all take different kind of medication, and it is vital that the medication that we consume has been scientifically tested to prove both its safety and efficacy. A properly conducted clinical trial is the only way to ascertain this. Firstly, the product is tested on animals (Pre-Clinical Research) and then when favourable results are obtained, they are tested on human patients and/or volunteers in 4 different phases:

Phase 1 involves testing in a very small number of patients who are closely monitored with the main objective being SAFETY.

Phase 2 involves testing the product is a much larger pool of patients who are also closely monitored with the main objective being SAFETY and THERAPEUTIC EXPLORATION.

Phase 3 involves further testing of the product in many patients who are monitored with the main objective being SAFETY and THERAPEUTIC CONFIRMATION.

Phase 4 involves the final phase of testing wherein the product is given to huge numbers of patients and then followed up with close SURVEILLANCE. For more specific details and queries on Clinical Research, please do get in touch with RKM Clinical Research and we will be more than happy to enlighten you. PATIENTS CORNER If you or any known person is suffering from any disease and would like to contribute to the advancement of new treatment therapies, do join us and let us know of your interest. We will help you help the healthcare industry.