05 — BA/BE & Clinical
Clinical evidence, coordinated through experienced partners.
OutcomePartners receive study data that connects directly to the product and process we developed.
01
Bioequivalence study designs
Studies run in line with international regulatory requirements and are monitored by an independent quality assurance function at the research organisation.
- Single- and multiple-dose studies
- Fasting and fed studies
- Drug–drug interaction studies
- Pharmacokinetic interaction studies
- Pharmacodynamic studies
- Food-effect studies
- Crossover and parallel designs
- Replicate designs
- Proof-of-concept studies
- Special populations (postmenopausal, adult female, geriatric)
- Comparisons between routes of administration
- Immediate- versus modified-release comparisons
02
Dosage forms and routes
Study capability spans the dosage forms we develop, which keeps the clinical plan tied to the formulation work.
Oral
- Tablets and capsules
- Suspensions
- Buccal
- Sublingual
- Lozenges
Injectable
- Intravenous
- Intramuscular
- Subcutaneous
Other routes
- Inhalers
- Transdermal patches
- Nasal sprays
- Suppositories
- Ointments and creams
03
Clinical trials with Voxtur Clinical ResearchV-10
Observational, interventional and marketing trials, from stand-alone services to full-service studies, coordinated through our sister concern.
- Phase I–IV clinical trials
- Patient recruitment and retention
- Study monitoring
- Medical writing and reporting
- Biostatistics
- Pharmacokinetics and pharmacodynamics
- Regulatory audits and consulting
- Clinical data management
- Medical monitoring
- In-house diagnostic services
- Molecular diagnostics (prenatal and newborn screening)
Start a conversation
Where does your programme stand?
Tell us the molecule, the dosage form and the market you are filing in. A programme lead will read it and reply with what we would do next.
Business enquiries: vasanthi@kmshc.com · +91 97898 75194V-23