Navitas Life Sciences has proven expertise in a wide variety of Bioequivalence studies which include variation in doses, dosage forms, single and double blind, dose escalation, PK/PD end point studies, Glucose clamp studies, proof of concept and exploratory, repeat “first in man”, nutritional, special population, drug interaction, injection study, inhalation study and many more. We understand the strategic importance of delivering high quality studies which is why we have an impressive record with the FDA
BABE Studies Conducted
Bioanalytical Methods Developed
We have capabilities in conducting simple generics, complex generics (including patient-based bioequivalence (BE) studies, and clinical end-point BE studies), as well as specialized studies (euglycemic clamp studies, and inhalation studies). We also have the capabilities to support your clinical data standardization & analysis, regulatory submissions management, and pharmacovigilance needs.
Our 3 Clinical Pharmacology Units have 208 beds to meet all your study needs. Our 2 state-of-the-art, GLP, 21 CFR Part 11 compliant labs house 12 triple quad mass spectrometers and 1 ICPMS.
Maintaining high quality clinical testing
To find out how well our clinical testing labs function, we met with Mr. Vijay Kumar, Senior Manager, Clinical Testing Labs, to gain vital insights.
Tell us more about yourself?
I am a postgraduate in Clinical Biochemistry. I have around 13+ years of professional experience in the Laboratory medicine domain, covering clinical testing and laboratory management at Navitas Life Sciences Limited.
I started my career with Acunova (now Navitas Life Sciences) involving myself in the clinical laboratory affairs being responsible for testing & review, proficiency testing, inter-laboratory comparisons management, accreditations, vendor management, and overall laboratory management.
Currently, I am serving as Senior Manager-Clinical Testing Laboratory, Manipal (Navitas Life Sciences) enabling technical support to the lab team, technical oversight of NABL and CAP certification conformity, and supporting the Laboratory Director for the overall Lab Management.
Clinical testing Laboratory
Navitas Life Sciences
I am a certified CAP inspector and authorized signatory per NABL. Currently, I am serving as Senior Manager-Clinical Testing Laboratory, Manipal (Navitas Life Sciences) enabling technical support to the lab team, technical oversight of NABL and CAP certification conformity, and supporting the Laboratory Director for the overall Lab Management
What is your goal or purpose?
We as a professional Clinical Testing laboratory strive to meet and exceed quality expectations on the basis of international best practices for all stakeholders of our laboratory services
Clinical testing laboratory has identified the following quality objectives which are consistent with the Quality Management System deployed at the Laboratory and are monitored regularly on a periodic basis.
- Reduction in errors (Quality)
- Reduction in cycle time (TAT)
- Regulatory Compliance and Adherence to ethical standards
- To ensure security and confidentiality of customer information
- Reduction in operating cost
Please describe the services provided by clinical testing lab and the workflow?
We are a NABL (National Accreditation Board for Testing and Calibration Laboratories), and CAP (College of American Pathologists) accredited Clinical Laboratory providing exclusive services to the clinical Research Services of Generics Business Vertical of Navitas Lifesciences. To enable the clinical testing services, we have enabled collection centers at Clinical facilities, and we receive screening samples from the collection centers connected to the respective Clinical facilities. We commonly perform dozens of different tests on serum or plasma. These tests, mostly automated, include quantitative testing for a wide array of assays like biochemistry, hematology, clinical pathology, and serology analysis.
Schematic representation of regular workflow in the lab
A phlebotomist will draw the specimens at collection centers needed for testing.
Once the specimens are collected, entry of test requests onto the LIS system and unique number is assigned by the LIS
Barcode sticker is generated and labelled on the tubes or specimen containers and transferred to laboratory
Sample processing will start with a set of samples arriving with a test request, via the laboratory information system
The samples are verified upon receipt for sample integrity and labeling accuracy.
Barcode labels are scanned by automated analyzers and test requests are pulled by the analyser from LIS
Samples are accordingly analyzed by the instruments and the obtained results are uploaded to the LIS
The uploaded results in LIS are reviewed by laboratory scientists and release for further approval
The pathologist can access the results and approve through LIS where he/she will review and make medical decisions based on the results.
Are there any significant challenges that you face in the work that you do?
Planning of work schedule for the team as the time of sample receipt is highly dynamic as it involves availability of subjects and relevant screening procedures.
Turnaround time is most critical as the test results determine if the subject can be included in the study.
Handling all the samples considering they are possibly contagious and can be confirmed only post-analysis.
Other than the LIMS system, what are the other instrumentations that you have?
Biochemistry sample analyzer - Vitros 250 which can process up to 350 samples per hour.
Hematology sample analyser - Sysmex XS 1000i which is a high throughput instrument. It can process each sample within one and half minute.
Urine sample analyser - Cobas U411.
Serology sample analyser - Vitros ECi immunoassay analyzer is the instrument which works on principle of Antigen-antibody reactions. It takes about one hour to process each sample and subsequent results are provided within 3 minutes.
All the above-mentioned instruments are integrated to LIS for ease of data handling, report sign off and delivery.
How many different projects are you associated with?
We are part of almost all clinical studies being executed across our clinical facilities. For this purpose, we have established two laboratories at Manipal and Chennai both the laboratories are accredited with NABL and CAP.
What happens if there is some anomaly? If there is something in the report, is it flagged and taken as an action item?
In case the values for any test performed are marginally beyond the established range they will not be evaluated further and reported.
Samples with anomalous results will be taken up for further evaluation as per pathologist discretion prior to reporting. It will be discussed with the principal investigator taking into consideration the history of the subject that may corelate with such values. To cite an example is positive sample for HIV. Subject cannot be included for participation in the study as well as in the subject safety concern it will be evaluated further with reference to NACO guidelines.
How many samples do you analyze per day?
On an average, 40 to 50 samples are analysed per day, with the highest number being 120 and the lowest around 10.
What are the various regulations and accreditations that are relevant for a diagnostic lab?
We are accredited with the national agency NABL (National Accreditation Board for Testing and Calibration Laboratories) as well as international accreditation from CAP (The College of American Pathologists). We are privileged to have both accreditations since 2007.
Accreditation for Our Clinical laboratories
NABL (National Accreditation Board for Laboratories; ISO15189-2012)
CAP (College of American Pathologists)
Our facilities, systems and processes have been inspected successfully by
USFDA, WHO, EMA (ANSM/AGES), Thai FDA, NPRA & DCGI
What has been the most memorable experience working at the lab?
First NABL and CAP accreditation audits faced in the year 2009 as it was a new experience working in such atmosphere. To add on, the most memorable were the moments when I was declared as a signatory by NABL as well as being qualified as inspector for CAP audits.
Do you have a service agreement saying that you should provide the reports within one day?
Service agreement would not be applicable as we cater to inhouse samples only and donot handle any external samples.
Do you have a list of audits that are conducted and the observations that are recorded?
NABL and CAP are the audits that occur biannually and we have been audited and accredited by both the agencies since 2007 without any major observation.
Staying Inspection Ready
- Strict adherence to Regulatory requirements
- Robust Quality Management System based on ISO 9001:2015
- Scientifically structured Standard Operating Procedures
- Execution of necessary checks
- Well-defined Quality Control
- Strong quality focused leadership
How regular are audits?
The major accreditation audit like NABL and CAP are biannual, audits by other regulatory audits like USFDA every 3 years. Sponsor audits happen quite frequently.
We are privileged to have both NABL and CAP since 2007 considering that we are one among 50 labs across the country with CAP accreditation and 300 labs having NABL accreditation
Gain from Navitas Life Sciences’ Inhalation Study Expertise Conduct Your Inhalation Study
- Highest level of Compliance to Regulatory Requirements
- State of the Art Infrastructure
- Readily Available Bioanalytical Method
- Precise Dosage across Volunteers
- Dosing in segregated area & videography
- Negative air chambers to prevent cross contamination