Notrox Research Bioequivalence Studies and CRO Services for Drug Development
Notrox Research is a contract research organisation (CRO) that conducts clinical trials for pharmaceutical companies.
Specialising in bioequivalence studies comparing approved drugs against generic formulations, the company provides high-quality data from trials conducted by highly trained staff in state-of-the-art facilities. All studies are performed in accordance to good clinical practices (GCP).
Notrox Research has a 25,000ft² clinical facility in Salem and a bioanalytical facility in Bangalore, India. The company conducts studies for the US Food and Drug Administration (FDA), Health Canada, and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Clinical studies and laboratory services for clinical trials
Notrox understands its clients’ needs and the importance of regulatory strategies in drug development. It provides high-quality, cost-effective clinical pathology laboratory services, which support pre-clinical studies or clinical trials.
The experienced research team has extensive knowledge of human haematology, urinalysis, coagulation, and clinical biochemistry, as well as therapeutics, international regulation, and operations optimisation.
Clinical study services also help ensure timely enrolment of patients and successful trial conduct. The company assesses proposed studies to optimise various aspects, including regulatory issues and approval, enrolment limitations, logistics, timelines, trial materials, and epidemiology.
Custom bioanalysis and pharmacokinetics laboratory services
Notrox provides specialised, custom laboratory services for assays, bio-markers, or drug safety studies.
Performed in good laboratory practice (GLP) compliant laboratories, the company has an extensive list of bioanalytical services for all stages of drug development and commercialisation, including the transfer, validation, and analysis of samples for multiple biological species and matrices; state-of-the-art assay development; and metabolite identification.
The bioanalytical methods available for measuring compounds include liquid chromatography-mass spectrometry (LC-MS), mass spectrometry (MS), and high-performance liquid chromatography (HPLC). The laboratories provide accurate, high-quality results and are staffed by scientific experts.
The Notrox team also has extensive experience in providing statistical services such as study design, analysis plans, clinical data review, project programming, data tabulations, statistical analysis, and reporting. These have applications in Phase I-IV trials, non-interventional studies, and integrated safety summaries for submission.
Customised drug clinical study solutions
Using flexible service models and thorough quality control processes, Notrox designs a range of customised clinical trial and laboratory solutions involving:
- Pharmacokinetics (PK) / Toxicokinetics (TK) analysis
- Bioequivalence and bioavailability
- Single or multiple dosing
- Intravenous glucose tolerance test (IVGTT) / glucose tolerance test (OGTT) and glucose clamps
- Meal interference / glycemic challenge
- Parenteral, including intravenous (IV), intraperitoneal (IP), subcutaneous (SC), and intramuscular
- IV infusion
- Rectal / intravaginal
- Dermal / intradermal / transdermal patch
- Oral, including gavage, liquid, tablets, and capsules
- Vascular access ports (VAP)
- Intracoronary / intraventricular
- Rodent vascular and non-vascular cannulas
Quality assurance and regulatory affairs for drug development
Notrox’s quality assurance (QA) team ensures adherence to international regulations, including the FDA, Canada’s Health Products and Food Branch Inspectorate, and ANVISA throughout all stages of clinical development. In addition, all offered clinical and bioanalytical services comply with GCP, GLP, and International Conference on Harmonisation (ICH) GCP guidelines.
As part of the company’s commitment to continuous improvement, Notrox measures, assesses, and reports quality data, which is monitored to maintain performance. The corrective and preventive action (CAPA) process investigates out-of-specification events, deviations, and discrepancies to allow the implementation and documentation of corrective actions.
Maintenance is also a key area of focus for Notrox, ensuring operational equipment is appropriately maintained.
QA services include:
- Clinical and analytical laboratories
- Ethical committee
- Suppliers / vendor
- Computer systems
- Study deliverables
- Case report form (CRF)
- Clinical study reports
- Tables and listings
- Regulatory inspection preparedness
- Provide training to staffs for regulatory inspections
- Assist preparing responses to inspection findings
- Conduct FDA and MHRA mock regulatory inspections
Regulatory affairs and project management
Notrox’s scientific and regulatory affairs department assures the goals of a clinical study meets regulatory guidelines. Clinical trial applications (CTA) can also be developed to meet legislative requirements and the team can attend ethic committee meetings to help convey that information to speed approval.
The company’s project management team has extensive experience in coordinating clinical trials across a wide range of therapeutic areas, and utilising numerous different study designs. The project managers are responsive and provide clients with immediate, long-term support.
In addition, Notrox’s project managers work closely with external contractors and sponsors to ensure timely communication.
Notrox Research aims to provide ethical drug development and clinical trial management in accordance with industry standards.
The company’s state-of-the-art clinical facility in Salem has a 100-bed capacity in three units, which allows three studies to run simultaneously. It also features two intensive care units (ICU).
Notrox’s bioanalytical laboratory located at Bangalore has the capacity to analyse 10,000 samples a month.
The laboratory includes a wide range of equipment, including:
- Sciex API 4000™ LC-MS / MS instruments
- Shimadzu Series HPLC
- Deep freezers running at temperatures of -86°C
- Freezers running at temperatures of -20°C
- Refrigerated centrifuges
- Solid phase extraction (SPE) manifolds
- Haematology analysers
- Wireless temperature data monitoring
Products and Services
Notrox Research has announced successful completion of a US Food and Drug Administration (FDA) audit conducted as a part of the routine Bioequivalent Clinical Bioresearch Monitoring (BIMO) inspection programme.Read more
No. 1364, 41st Main road,
J.P.Nagar 1st Phase, Ground floor Sarakki Gate, Kanakapura Main Road
No. 18, Tanmag Road
Sharon Campus Vinayagampatti
United States of America