Clinical Research
Clinical Operation
Our Clinical Operations team manages Phase II–IV clinical trials with the highest standards of ethics, quality, and confidentiality. We believe in a strong team culture built on collaboration, accountability, and continuous development.
To ensure our clients receive quality monitoring services in full compliance with regulatory guidelines, we invest in comprehensive training and development for our Clinical Research Associates (CRAs).
Medical monitoring
At Medivdpharma, we know that patient safety is the top priority in every phase of clinical research. Our medical monitors—experienced physicians and therapeutic specialists—provide expert oversight and medical management throughout clinical trials.
With extensive training across diverse therapeutic areas and technologies, our team ensures high-quality medical review and decision support. Our monitors can work independently or integrate seamlessly into sponsor teams as needed
Clinical Data Management
Our Data Management team ensures seamless collaboration with CRAs, Project Managers, Clients, and Investigational Sites. We use validated systems (Oracle Clinical 4.6) compliant with FDA 21 CFR Part 11 and GCP standards to guarantee data quality and integrity.
We manage studies from Phase I to Phase IV, supporting global trials with a focus on fast start-up, efficient workflows, andreal-time data access. Our advanced reporting tools provide full visibility into study progress—delivering accurate, submission-ready data on time.
Biometrics
Our statisticians and programmers deliver reliable data analysis for endpoint determination, statistical evaluation, and customized data presentation aligned with regulatory requirements.
We design, analyse, and report Phase I–IV clinical trials across multiple therapeutic areas, always keeping the Sponsor’s goals at the centre. Quality and flexibility define our approach, supported by peer review through dual independent programming and rigorous QA checks on all outputs.
Medical writing
At Medivdpharma, we know that clarity, accuracy, and compliance are critical throughout every phase of clinical research. Our Medical Writing team—composed of experienced physicians and therapeutic specialists—provides expert medical documentation and review to support clinical trial activities.
With deep expertise across a wide range of therapeutic areas and technologies, our writers ensure every document meets regulatory and scientific standards. They can work independently or integrate seamlessly within Sponsor teams to deliver timely, high-quality submissions.
Regulatory affairs
Bringing a new product from development to market approval is complex, costly, and time intensive. Delays can quickly increase both time and budget. At Medivdpharma, our experienced Regulatory Affairs teamsupports clients through every stage of the drug development process—from early consultations and clinical trials to marketing authorization submissions.
With proven expertise in managing diverse regulatory challenges, we help clients meet demanding timelines and compliance requirements. We offer end-to-end regulatory support or customized servicestailored to your study needs.
Pharmacovigilance
We provide Pharmacovigilance services to ensure product safety throughout both pre-marketing and post-marketing stages of drug development. Our dedicated team of trained Pharmacovigilance specialists and physicians expertly handle the recognition, processing, analysis, and reporting of adverse events to deliver high-quality safety surveillance across all clinical phases.
We stay fully aligned with local and global safety reporting requirements, maintaining strict compliance with 21 CFR Part 11and GCP standards for Pharmacovigilance operations.
Quality assurance
The Quality Assurance (QA) team at Medivdpharma ensures that every service meets global quality standards. Our independent QA unitconducts audits as part of both study-specific quality strategies and our internal Quality Management System (QMS).
Our QA auditors work closely with project teams to promote compliance, consistency, and continuous improvement in clinical research. Quality isn’t just checked—it’s built into everything we do.