The absence of a substantial difference in the rate and degree of absorption of the active ingredient that enters the systemic circulation is referred to as bioequivalence (bioavailability). It is assumed that products with similar bioavailability will have similar therapeutic effects. Bioequivalence investigations are carried out according to well-defined processes and include the following steps:
There are 20 distinct dose forms available:
We have in-house medical writing professionals who are responsible for generating study materials in accordance with applicable regulatory advice and the sponsor’s requirements.
Maven Clinical Research Pvt Ltd provides a full range of clinical or bio-equivalence research management services, from feasibility review through clinical study report filing, in accordance with regulatory bodies’ and protocol-designed protocols. The process of managing the execution of pilot and pivotal bioequivalence studies, including the preparation of product feasibility, document finalisation and regulatory services, and interpreting pharmacokinetic and statistical bioequivalence results to clinical study report submission is a long and complicated one. We have in-house project managers who serve as a single point of communication between the Sponsor and Maven. They are in charge of project planning, monitoring, control, and closure.
Maven has a lot of experience with glucose clamp studies, which are commonly used to discover new approaches to treat metabolic illnesses like diabetes, obesity, and fatty liver. Maven’s clinical experience and professional expertise, as evidenced by the huge number of glucose clamp tests completed, have earned us the trust of a variety of national and international clients. Maven’s focus to data quality without affecting participant well-being and safety demonstrates the company’s commitment to clinical trial transparency, safety, and ethics.
Maven has conducted Transdermal Patch Studies, Bioequivalence (BE) studies with pharmacokinetic (PK) endpoints and adhesion studies, as well as skin irritation and sensitization studies (Proof of Procedure). A proof-of-concept study to assess skin irritation parameters, identify study obstacles, and assess the cumulative skin irritation potential of test goods (Control solutions) in healthy adult human volunteers under occlusive patch settings.
Topical medication delivery techniques include inhalation products. They are administered through the lungs. To standardize the dosage technique, these studies require professional staff, adequate equipment, and intensive training for volunteers. We are aware of your requirements. Maven’s cutting-edge infrastructure and track record of success in terms of regulatory compliance, quality, and ethics make it a go-to CRO for flawless inhalation study management and execution.
Maven has conducted a number of research involving suppositories. Database of cooperative volunteers who have previously participated in similar investigations. Dosing techniques are carried out by trained and experienced personnel who follow procedures. Clinics and pharmacies with temperature and humidity control to help with IMP handling.
Maven provides best-in-class services to conduct Patient-based Bioequivalence studies for various 505 B2 and complex generic drugs for our drug development clients, combining expertise and experience in bioequivalence studies. To conduct patient PK tests and clinical end point studies, we collaborate with leading hospitals and investigators. We have extensive expertise performing research in all main therapeutic areas, such as oncology, psychiatry, ophthalmology, and dermatology.
We offer project planning services to ensure that quality is built into PK studies from the outset, including risk mitigation techniques, efficient and effective schedule and budget planning, and performance optimization. Risk Management Plan, Safety Management Plan, QA Audit Plan, IMP Plan, Data Management Plan, Edit Check Plan, Monitoring Plan, Project Management Plan, and PK Sample Management Plan are all things that the team has worked with before. To carry out all of these ideas, the team has received extensive training. Most importantly, project managers are always prepared with a risk mitigation strategy in case of unforeseen circumstances during a PK investigation.
Study procedure development, source document review, patient eligibility confirmation, patient compliance tracking, supply inventory management, adverse event reporting, regulatory compliance monitoring, and regulatory documentation maintenance are all part of our clinical end point studies monitoring services. Across all research, project managers provide solution-focused project management. They are a single point of contact for Therapeutic Equivalence studies and have extensive experience with them. They can help you understand your recruiting issues, assess the impact of competitive trials, and improve patient access and retention. They offer responsibility and transparency, as well as a track record of accomplishment. Timelines and hazards are proactively controlled, based on previous experience, to enable effective study management.
We have a large database of investigators and site associations that allows us to quickly identify suitable investigators and their patient groups, which helps us meet our enrolment goals. We also provide training to investigators and site workers on protocol requirements, industry best practises, and technology options such as electronic data capture.