#101, VPG House, Varthur Main Rd, Whitefield Mon-Sat 09am-5pm, Sun Closed NABL Accredited (M(EL)T-03030)

NABL Accredited · NABL-M(EL)T-03030 GCP / GLP Compliant

Clinical Trial Sample Processing Lab in Bangalore

Precision diagnostics, research ready. Niyamit Health is a pathologist-led, fully automated lab in Whitefield that processes clinical trial samples for CROs and pharma companies, with full chain of custody, cold chain logging and GCP/GLP-compliant reporting.

15+Years of pathology experience
3+Years of CRO experience (Authorized Signatory)
~200/hrTest processing capacity
4 hrsMinimum TAT after sample receipt

Why CROs Choose Niyamit

Founded by Dr. Priyanka Somwanshi, MBBS (KEM Hospital, Mumbai) and MD Pathology (VIMS & RC, Bengaluru), Niyamit was built with a research-oriented approach. Workflows and documentation have been aligned to research-grade requirements from day one.

CRO-Trained Leadership

Dr. Priyanka has 3+ years of direct CRO experience as an Authorized Signatory, so we understand your protocols, timelines and audit expectations from the inside.

Research-Oriented by Design

Infrastructure, workflows and documentation built for clinical research, with protocol-customised workflows for each CRO.

Therapeutic Area Focus

Oncology, Metabolic Disorders, Gastroenterology and Infectious Disease, the trial-heavy areas our research background is aligned to.

NABL Accredited + Roadmap

NABL-M(EL)T-03030, valid June 2025 to June 2028. Processes are already aligned to full NABL, and ISO 15189 accreditation is actively in progress.

Full Cold Chain + Chain of Custody

Barcode tracking on LiveHealth (Crelio) LIS, cold chain with temperature logs every 15 minutes, and chain of custody from collection to archiving.

GCP & GLP Compliant

Documented GCP/GLP compliance. Audit experience across NABL, CAP, GCC and pre-qualification CRO audits, with records always audit-ready.

Core Diagnostic Services

  • Hematology (CBC, Peripheral Smear)
  • Biochemistry (Metabolic, Liver, Kidney panels)
  • Serology & Immunology
  • Clinical Pathology (Urine, Body Fluids)
  • Cytology: FNAC & Gynae Cytology
  • Histopathology & Biopsy Processing

CRO & Research Capabilities

  • GCP & GLP-compliant reporting
  • Protocol-customised workflows per CRO
  • Chain of custody from collection to archiving
  • Cold chain with 15-minute temperature logs
  • Home collection & multi-location pickup across Bangalore
  • Dry-run / mock sample runs on request
  • Co-development of lab manuals & SOPs
  • Flexible TAT, minimum 4 hours after receipt; STAT on request

How a Trial Sample Moves Through Our Lab

01

Collection

Home collection and multi-location pickup. Barcode labelling at the point of collection starts the chain of custody.

02

Transport

Cold chain maintained throughout, with temperature logged every 15 minutes across an active Bangalore logistics network.

03

Registration

Barcode-based registration on LiveHealth (Crelio) LIS, with real-time logging and a full audit trail from the first entry.

04

Analysis

Fully automated, bidirectionally interfaced analysers (~200 tests/hour). Daily internal QC plus EQAS external benchmarking.

05

Reporting

Minimum 4-hour TAT after receipt. Protocol-adapted report templates, delivered by encrypted transfer or API integration.

06

Archiving

Record retention per GCP/GLP/NABL guidelines. Calibration, QC and EQAS logs available for audit at any time.

Turnaround Time by Test Category

Test categoryRoutineUrgent
Hematology (CBC, ESR)4–6 hrs1–2 hrs
Biochemistry panels6–8 hrs2–4 hrs
Serology / ImmunologySame day4–6 hrs
Clinical Pathology4–6 hrs2 hrs
Histopathology / Biopsy3–5 days24–48 hrs
Cytology (FNAC)2–3 daysSame day

Trial Visit Window Scenarios

VisitTypical testsSamplesTAT
ScreeningCBC, Biochem, Serology, Urine8–156–8 hrs, same day
Day 1 DosingCBC, Biochem, Coagulation, LFT10–204–6 hrs (STAT)
Follow-upCBC, Biochem, UA, Serology6–124–6 hrs
Safety MonitoringCBC, Metabolic Panel, LFT, RFT8–156 hrs / 2 hrs STAT

All TATs are from sample receipt. STAT available on request. Custom windows are agreed in a study-specific MOU. Daily reporting logs are shared for trial visibility.

Quality, Compliance & Infrastructure

Accreditation & Registration

  • NABL-M(EL)T-03030, valid Jun 2025 – Jun 2028 (NABL 128 criteria)
  • ISO 15189 on roadmap
  • Karnataka Private Medical Establishment (KPME) registered
  • Biomedical waste (BMW) management authorised
  • EQAS participation via RML and other national schemes

Lab Infrastructure

  • Erba XL 200 biochemistry, Erba H560 hematology and EC90 analysers
  • 100% automation: pre-analytical, analytical and post-analytical
  • Barcode-based sample tracking
  • Temperature-monitored sample storage
  • Backup power for zero downtime

Data & Confidentiality

  • LiveHealth (Crelio) LIS with role-based access
  • Every entry and change timestamped in the audit trail
  • Encrypted result transfer
  • API integration with CRO platforms
  • All records available on-site for regulatory inspection

Documents Available for CRO Review

All documents are maintained, current and available for inspection at any time, including pre-qualification CRO audits and regulatory site visits.

  • Full QMS documentation and records
  • Instrument IQ / OQ / PQ, calibration and service records
  • EQAS participation records
  • NC, CAPA & risk management records
  • Supplier qualification records
  • Inventory and reagent expiry logs
  • Validated sample stability data
  • Staff competency and training records
  • LIS verification (IQ / OQ / PQ)
  • Daily QC logs and instrument run records
  • SOPs, manuals and audit trail reports
  • Chain of custody records

Research Work & Academic Expertise

Completed

AI-automated Ki-67 scoring in sarcoma

Applying AI to automate Ki-67 proliferation index scoring in sarcoma histopathology.

Completed

AI-based Gleason scoring in prostate carcinoma

AI models applied to standardise Gleason grading in prostate cancer pathology.

Completed

HER-2/neu in gastroesophageal adenocarcinomas

Histopathological study of upper GI endoscopic biopsies with emphasis on HER-2/neu detection, relevant to targeted therapy eligibility.

How We Like to Work With CROs

Long-term partnerships

Sustained relationships with CROs and pharma companies, not just project-by-project work.

Pilot or dry-run first

Start with a mock run or pilot phase so your team is confident before committing to a full study.

Protocol co-development

We co-develop lab manuals and SOPs tailored to your trial protocol.

Dedicated single point of contact

One SPOC per CRO client, with daily coordination touchpoints for project managers.

Location & Network

We are in Whitefield, Bangalore's most active corridor for clinical trials, research hospitals and technology parks, with easy access to the city's pharma and biotech cluster and major CRO offices.

Hospital network: Medicover, Devi Eye Hospital, Dino Hospital, Lions Airport City Hospital and Laxmi Nursing Home.

Address: #101, 1st Floor, VPG House, Ramagondanahalli, Varthur Main Road, Whitefield, Bengaluru 560066.

Let's Partner

Think of us as your diagnostic backbone: precise, professional and research-ready. Tell us about your study and we will get back to you.

Dr. Priyanka Somwanshi, CEO & Founder

+91 96065 64032

info@niyamithealth.com

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Niyamit Health Diagnostic

#101, 1st Floor, VPG House, Varthur Main Rd, Whitefield, Bengaluru 560066

+91 9606564032

niyamithealth@gmail.com