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Early Clinical Drug Development

Phase I, First-in-Man, Drug - Drug Interaction studies (DDI) & Bioavailability (BA)/Bioequivalence (BE)

Our fully air conditioned facility, spread over 45,000 Square feet, is a one -stop centre for your entire BA/BE studies. With a total of more than 280 beds spread across 3 independent clinics (one) with separate rooms available for women housing, MTR is well positioned to cater to the global Regulatory requirements

  • Phase I (First-in-Human) with extensive monitoring and Bioavailability (BA), Bioequivalence (BE), Pharmacokinetics (PK), Pharmacodynamic (PD), Interaction studies (drug/drug, drug/alcohol), Dose Escalation (SAD/MAD), Safety & Tolerability, Dose Ranging and Vaccine studies
  • Extensive experience with a variety of dosage forms including immediate release (IR), controlled release (CR) modified release (MR), extended release (ER), solid oral, oral thin films (OTF), oral dispersible tablets (ODT), sublingual, suppositories, inhalers, injections, patches, suspensions and nasal spray

  • A vigorous QC process to ensure data integrity

  • Experience in working with a broad variety of therapeutic areas including cardiovascular, infectious diseases, psychiatric, gynaecological, endocrine, neurological, anti-inflammatory, anti-infective, analgesic, gastrointestinal, respiratory, urological and dermatological

  • Proximity to emergency facilities

  • State-of-the-art emergency and resuscitation equipment

  • Dedicated controlled access pharmacy with continuous temperature & humidity monitoring

  • Provides ECGs & EEGs, Pulmonary Function Testing (PFT), Cognitive Drug Testing (CDR), Gastroesophageal monitoring, Cardiac monitoring, Radiology (X-rays, MRIs)

  • Clinical team comprised of medical doctors, registered nurses, technicians, and medical assistants

MTR has the expertise to offer you the entire range of services for First-in-Man and Phase I clinical trials. Our capabilities are designing the protocol, conducting the study, generation of the clinical study report and the regulatory submission.

Expertise in conducting Phase I studies in

  • Healthy volunteers

  • Geriatric population

  • Postmenopausal/Surgically sterile women

  • Hypertensive patient population

  • Asthma patient population

  • Patients with renal and hepatic impairment

  • Patients with chronic obstructive pulmonary disease

  • Type 1 and Type 2 diabetes patients

  • Patient population of various cancers

Service

  • Phase I studies (First-in-Man)

  • Drug-Drug interaction studies

  • Drug-Food interaction studies

  • Proof of concept studies

  • Safety and tolerability studies

  • Dose ranging studies

  • Early patient studies

LIST OF BA/BE STUDIES SUBMITTED Click here

LIST OF BE STUDIES CONDUCTED Click here


Early Clinical
Bio analytical Services
Clinical Trials
Pre Clinical Services
Biosimilar
Analytical
Diagnostics
Scientific Affairs
Project Management
Quality Assurance
MTR has successfully cleared USFDA Inspection

MTR Preclinical Facility accredited by GLP

SCRI – Research Center  recognized  by ANNA UNIVERSITY
,
for pursuing Ph.D. and M.S. (by research).
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