CLINICAL DEVELOPMENT SERVICES

We, Clinical development team in Medica Innova, broad knowledge and experience in clinical trials from clinical trial design (Phase I-IV), interpretation and execution to the preparation and submission of data to regulatory in ASEAN countries.

Clinical Planning & Strategic Consulting

Provide scientific input for clinical development plans to achieve regulatory and scientific objectives for Chemical & herbal medicines and medical devices

- New chemical entities

- New dosage forms

- New combinations

- New strengths

Clinical Trials (Phase I-IV) including Bioequivalence / Bioavailability

Provide expertise and clinical input to Clinical trials

- Bioavailability and Bioequivalence studies

- Dose Escalation, First-in-Human and Food Effect studies

- Drug-Drug Interaction Studies

- Special Popuation Studies; Hepatic and Renal Impairment Studies

- Efficacy/Proof of Concept Studies

offer

- Protocol Development

- Study Management

- Clinical Monitoring

- Clinical Pharmacology and Safety Data Analysis

- Clinical Study Report Development

Clinical Monitoring

We work in compliance with ICH-Good Clinical Practice (ICH-GCP) to ensure the clinical data and reported results are credible and accurate, and subjects right, integrity and confidentiality are protected.

offer

- Pre-study & initiation visits

- Monitoring visits

- Close out visits

- Management tasks

Bioanalysis

In bioanalysis, we value your projects with comprehensive, innovative, and OECD-GLP certified bio-analytical assays. All development and validation processes are performed according to the most recent EMA, FDA, and ASEAN guidelines.

offer

- Development and Validation of New Assay

- Method Transfer and Optimization

- Analysis of Biological Samples