FAQ's
What is InrexTest?
InrexTest is a Contract Research Organization ("CRO"). We provide testing services
at all stages of development within the life science spectrum including Medical
Devices and Pharmaceuticals. InrexTest facilitates preclinical and clinical testing
services from study design through data collection and report writing.
Is InrexTest a lab or hospital?
InrexTest is neither a lab nor a hospital. We contract with accredited facilities
that have the expertise and technology to perform your testing to the highest standards,
negotiating to get you the best prices and execution.
How can InrexTest help me in my project or study?
InrexTest’s technical staff has the training and expertise to assist you in every
aspect of your project development and approvals.
- Study Plan and Design: We listen to you so we are sure we understand your project
goals, testing needs and constraints. Based on these we can help in planning and
designing the preclinical and clinical studies.
- Lab Selection: Based on your requirements, we qualify and select the best partner
labs and clinics to meet your quality, timeline and financial goals.
- Lab auditing: Our technical team personally inspects and audits all partner labs
and clinics before and during the studies to ensure they maintain the quality of
infrastructure and expertise required for your studies.
- Meeting Coordination: Whenever required, we can facilitate client conferences, meetings,
and visits with the labs and clinical facilities.
- Study Monitoring: Our technical team regularly monitors the studies to ensure compliance
to study plans including timelines. Reports are provided expeditiously to our clients
for each monitoring visit giving transparent updates about the ongoing study status.
- Review: All data, documents and reports are thoroughly reviewed by our experts in
the relevant field before they are submitted to client.
- Project Management: Complete project management from planning and logistics to study
execution monitoring and final report development are managed by InrexTest’s professional
staff.
- Regulatory Consulting: Requirements for various regulatory agencies are different
and need to be strictly followed. We ensure that all requirements are duly met through
our studies and reports.
How does InrexTest work?
InrexTest partners with experienced laboratories and clinics worldwide to provide
you the highest quality and best pricing available in the industry. Since many of
our partner facilities are located in India, we maintain offices in Pune to support
legal, regulatory, and project management functions. By maintaining these functions
both in Pune and in our home office in New York City, we offer clients quick turnaround,
quality results, and highly competitive pricing.
Do InrexTest’s partners have International standards and accreditations?
InrexTest’s partner labs and clinics operate to international standards including
GLP, GCP, ISO10993, ISO 17025, AALAC, OECD, USFDA, CAPA and CLIA. We select the labs
based on the requirements of your project.
What services does InrexTest offer?
- Analytical Development
- Preclinical Research
- Clinical Research
- Microbiology and Sterilization testing
- Packaging Testing
- Biocompatibility
- Animal studies
How does InrexTest ensure confidentiality of client’s project?
Our partner labs are bound by confidentiality agreements with InrexTest. InrexTest
signs Non-Disclosure agreements with our clients as well. In this way InrexTest
ensure client’s confidential information at both ends.
Is InrexTest’s cost for testing lower than competitive labs?
InrexTest is able to provide lower costs to you due to lower labor costs and the
clout of our established relationships. We are also often able to provide you faster
turnaround times.
Does InrexTest provide the same quality as a Western Lab?
InrexTest’s labs meet the same International standards and have completed studies
for successful IND, IDE, ANDA, 510(k) and NDA submissions.