These research programs are specifically designed to evaluate the safety and effectiveness of new medicines, drugs, vaccines and other therapies. These trials are making healthcare effective and improving health. At Makolet, we are enhancing healthcare through a human- centric approach with efficiency, compliance and real-time visibility throughout the trial process.
We make sure to aid you in managing the clinical supply logistics efficiently and optimise your clinical trial services through a scalable approach. Our expertise streamlines preclinical and clinical trials through a scalable approach. We offer end to end clinical trial services starting from discovery to delivery.
Pilot study is a study that gives insight into the actions, efficacy and safety of a drug or a device. They are used to guide clinical and translational research for so many years. These are performed at the earliest stage of the development of a drug or device. In short, it is the research conducted in preparation for a larger investigation. In Pilot studies, it tests the key elements of the trial with the recruitment and retention strategies, intervention delivery, data collection methods and adherence to the protocol.
Pilot study plays a crucial role in the eventual implementation and distribution of the intervention under study by identifying barriers and facilitators. Pilot trials can be used to predict feasibility and effectiveness of a protocol design that is planned for a pivotal trial. Major advantage of pilot study is used to identify unpredicted harm early in the development of a drug or a device.
It is a clinical study used to demonstrate the efficacy of a new drug to obtain the marketing approval by regulatory authorities. The main aim is to determine whether the new
experimental drug has better efficacy when compared to another drug. These studies are not analytical trials. These are designed to test if a product’s performance exceeds that of another product.
Pivotal trials require a large number of patients, sites and in turn increases operational complexity. The aspect of a pivotal clinical trial protocol is the primary clinical objective/endpoint, the statistical design, the inclusion/exclusion criteria and the treatment. It helps us to learn more about the possible ways to treat people and find best ways to increase the number of treatment options.
Experience with Phase II to Phase IV studies, ranging from single centre studies with 20 patients to large trials with over 500 patients. At Makolet we have an excellent network of hospitals of all specialties, all over India.
We offer reliable and affordable Clinical End Point testing, where our experts from medical and scientific backgrounds can evaluate the clinical effect in the chosen population as per the protocol and submit a report in compliance to applicable regulations.
Makolet has access to KOL’s in each therapeutic area.