Life Sciences & Healthcare AI Practice · Part of Nika IT
Where AI meets
clinical reality.
clinical reality.
We build production-grade AI systems for biopharma, diagnostics, medtech, and clinical operations — combining deep engineering capability with firsthand life sciences expertise to deliver solutions where accuracy, compliance, and human oversight are non-negotiable.
7+
Bio engagements
10+
Years, Nika IT
CLIA
Lab background
CAP
Regulated ops
Clients include:
Roche / Genentech
·
Anchor Bioresearch
·
Specialty DX
·
Oncology Biotech
·
Global Pharma
·
Specialty Pharma
·
Medtech
What we build
AI for the hardest parts of clinical operations. We work across workflows that sit between the science and the clinical action — where data integrity, regulatory accountability, and human oversight are not optional.
Regulatory
Regulatory AI
RAG systems for NDA/IND submissions, FDA query responses, and regulatory intelligence trained on your own dossier history and current guidances.
Diagnostics
Precision diagnostics
Clinical report automation, AI-assisted result interpretation, false positive flagging, and provider communication platforms for specialty and molecular diagnostics labs.
Safety
Pharmacovigilance
ICSR triage, MedDRA auto-coding, signal detection pipelines, and safety database integrations for post-market surveillance at volume.
Clinical
Clinical operations
Trial site monitoring, enrollment forecasting, EDC integrations, and protocol deviation detection across multi-site Phase II/III programs.
Manufacturing · QC
Device manufacturing QC
Computer vision inspection for Class II/III device lines — 21 CFR Part 820 compliant, MES-integrated, real-time, sub-100ms per unit.
Medical Affairs
Medical affairs AI
MSL enablement platforms, KOL briefing automation, and on-label scientific content retrieval for global medical affairs teams.
Integration
FHIR & EHR integration
Compliant data pipelines connecting EHR systems, LIS, LIMS, safety databases, and clinical platforms.
Payer · RWE
Prior auth & RWE
Clinical criteria matching engines, prior authorization automation, and real-world evidence pipelines for payers and specialty diagnostics companies.
What we have built.
Seven engagements across pharma, diagnostics, medtech, and clinical operations — all designed with human oversight at every critical decision point.
Toxicology & Diagnostics AI
First-hand lab experience
Anchor Bioresearch — CLIA Lab, San Pedro CA
Automated false positive flagging and LC/MS result verification
High-volume toxicology lab with CLS team manually reviewing every presumptive immunoassay positive — cross-referencing medication history and verifying LC/MS ion ratios on every specimen. Nika built an automated flagging layer that stratified positives into high-confidence false positives, equivocal, and send-to-confirmation — with a pre-populated LC/MS review form highlighting only out-of-spec parameters.
–40%
Manual screen review volume
~30s
CLS time, clean LC/MS results
↓
Result release error rate
AI-based LIS integration
Immunoassay classification
LC/MS parameter validation
False positive flagging
CAP audit trail
Medication history cross-ref
Regulatory AI
Oncology biotech — confidential
Regulatory submission knowledge assistant
A clinical-stage biotech with 3–5 active IND/NDA programs and a regulatory affairs team too small for the pipeline. Every agency information request triggered hours of manual search through prior submissions, FDA meeting minutes, CMC development reports, and evolving ICH guidances. Nika built a RAG system on the company's full regulatory history — writers now query in plain English to pull precedent, check cross-module consistency, and draft agency responses in a fraction of the time, with every output traceable to source.
68%
Faster response
4.2×
Draft speed
$3.1M
Annual savings
RAG
Azure OpenAI
Veeva Vault
21 CFR Part 11
Pharmacovigilance
Large specialty pharma — confidential
Automated adverse event triage & MedDRA coding
A specialty pharma company processing 8,000–15,000 individual case safety reports per month across multiple marketed products — every one reviewed manually by a pharmacovigilance team that was becoming the bottleneck. Nika built an NLP pipeline ingesting cases from web forms, email, and EDI feeds simultaneously, classifying by seriousness and expectedness, suggesting MedDRA preferred term codes, and routing to appropriate reviewer queues — with a complete ICH E2B(R3)-compliant audit trail on every automated decision.
91%
Triage accuracy
–83%
Review time
17
New signals Y1
Custom NLP
MedDRA auto-coder
Argus integration
ICH E2B(R3)
Precision Diagnostics
Specialty diagnostics lab — confidential
AI-powered clinical report assembly platform
Thousands of multi-panel tests monthly, bottlenecked between assay results and physician-ready reports. AI layer ingests LIS outputs, retrieves NCCN/ASCO guideline context, and generates pre-populated draft for clinical reviewer approval. Human sign-off enforced. Full audit log.
–52%
Report TAT
–60%
Assembly time
97%
Acceptance rate
LIS integration
Guideline RAG
Reviewer workflow
CLIA/CAP
Medical devices
Class II/III manufacturer — confidential
Computer vision quality inspection on a regulated device line
Manual visual inspection was the highest defect-escape point and biggest FDA 483 exposure. CV system across 14 stations with custom CNNs on 200K+ labeled images, real-time MES integration, and auto-generated 21 CFR Part 820 inspection records in under 80ms per unit.
99.4%
Detection accuracy
–94%
Defect escapes
80ms
Per unit
Custom CNN
Edge inference
MES integration
21 CFR 820
Clinical operations
Phase II/III oncology biotech — confidential
Real-time trial site monitoring & enrollment forecasting
Clinical ops manually building weekly reports from EDC pulls across 80 sites. Live dashboard on Medidata Rave and Veeva Vault APIs surfacing site pacing, data query aging, and an ML layer flagging underperforming sites 3–4 weeks before standard reporting catches them.
–41%
Time to target
3–4wk
Early warning
80+
Sites live
FHIR R4
Medidata Rave API
Veeva CTMS
XGBoost
Medical affairs
Global pharma — confidential
MSL field enablement — AI-powered KOL briefing platform
500+ MSLs spending 2–3 hours prepping for each KOL meeting. RAG platform on live PubMed, internal MI databases, and Veeva CRM — AI-powered pre-meeting briefs in under 2 minutes. On-label compliance guardrails enforced at the model level. iOS and Android native apps.
–62%
Prep time
2 min
Brief generation
500+
MSLs live
RAG + re-ranking
PubMed API
Veeva CRM
iOS/Android
The team
Gene Stavtsev, MBA
Head of Business Development — Life Sciences
Gene Stavtsev combines big-pharma strategy experience from Amgen and Novartis with hands-on diagnostics lab scaling and AI-driven biotech innovation, giving him a uniquely cross-functional perspective on bioscience operations. At NIKA, this expertise is translated into production-grade AI solutions deployed across regulatory, pharmacovigilance, diagnostics, medical devices, and clinical operations — directly addressing complex, real-world challenges.
Daniel Kozhemyako
CEO & CTO — Nika IT
Daniel leads Nika IT's technical direction across all verticals. 15+ years building highly scalable, full-stack products across software engineering, QA, DevOps, and product strategy. He has led teams through complex implementations in regulated and mission-critical environments — combining deep technical depth with the execution discipline to deliver at scale. At Nika × BIO, Daniel oversees the engineering architecture and delivery of all life sciences engagements.
What clients say.
★★★★★
"We had a growing regulatory pipeline and a team that simply couldn't keep up manually. Nika built a system that understands our own submission history — our writers now spend time on judgment calls, not hunting through binders for precedent. ROI was visible within the first submission cycle."
VP Regulatory Affairs — Oncology Biotech
★★★★★
"Our PV team was drowning. 12,000 cases a month, two safety databases, and a manual triage process becoming a compliance liability. Nika's pipeline didn't just reduce hours — it surfaced signals we would have missed. That alone justified the engagement."
Global Head of Pharmacovigilance — Specialty Pharma
★★★★★
"We were producing thousands of reports a month and every one required manual assembly. What Nika built removes the 45 minutes of document construction before clinical judgment can be applied. Turnaround dropped and our staff are doing the work they were trained to do."
Chief Medical Officer — Specialty Diagnostics
★★★★★
"A 2.8% defect escape rate on a Class III line is not acceptable. The CV system Nika deployed catches what our inspectors miss, generates compliance records automatically, and does it in under a second per unit. Our last FDA inspection was the cleanest in six years."
VP Manufacturing & Quality — MedTech Company
★★★★★
"We were four weeks behind enrollment pace at the Phase II mid-point. The site dashboard Nika built showed exactly which sites were trending down early enough to intervene. We hit our enrollment target on time. That doesn't happen without the right data at the right moment."
Clinical Program Manager — Oncology Biotech
★★★★★
"Asking our MSLs to spend three hours pulling PubMed and CRM notes before every KOL call was a waste of exactly the expertise we hired them for. Nika's platform gives them a two-minute brief that's better than what took three hours. The field impact was immediate."
Head of Medical Affairs — Global Pharma
How we work
Built differently by design. Most AI vendors approach life sciences from the outside. We approach it from the inside — with lab operations experience, regulatory literacy, and engineering depth on the same team.
01
Lab-first perspective
Our BD lead has personally run CLIA/CAP regulated laboratories processing toxicology and molecular PCR at volume. When we ask about your workflow bottlenecks, we are not asking as outsiders. We know what the queue looks like when medical review backs up.
02
Human-in-the-loop by default
Every clinical system we build enforces human review at the decision points that matter. AI assists. Clinicians decide. We do not build systems that remove clinical judgment from the loop — we build systems that make it faster and better-supported.
03
Compliance from day one
CLIA, CAP, HIPAA, 21 CFR Part 11 and Part 820, ICH E2B(R3), FHIR. We plan for validation and compliance requirements at the architecture stage. We work with your compliance team, not around them.
What we are
- Engineers who build AI systems, workflow automation, and data pipelines for life sciences
- Experienced in regulated laboratory and pharma environments from the inside
- Committed to audit trails, access controls, and compliance documentation
What we are not
- A clinical firm — domain expertise stays with your scientists and clinicians
- A plug-and-play vendor with a pre-packaged product
- In the business of removing clinical judgment from the loop
Let's find the right first problem.
We are not looking for a platform commitment. We are looking for a 45-minute conversation with your clinical operations or informatics team — to understand where the real friction is, and tell you honestly whether we can help with it.
Part of Nika IT — 87+ projects · 11 global offices · 10+ years