Clinical Research ยท Data ยท Compliance

Evidence you can trust, trials that stay on track.

Pathway Clinical Solutions partners with sponsors, sites, and biotech teams to plan, run, and analyze clinical studies โ€” with rigorous quality and complete regulatory compliance at every step.

Clinical researcher working in a laboratory
5Service lines, one team
GCPAligned by design
DirectSenior access, always

What we do

End-to-end support across the clinical development lifecycle. Select a service area to see the details.

Clinical Trial Management

From protocol to close-out, we keep your study compliant, enrolled, and on schedule.

  • Study feasibility & site selection
  • Project management & monitoring (CRA services)
  • Vendor & site coordination
  • Safety reporting & pharmacovigilance support

Data Management & Biostatistics

Clean data, defensible analysis, submission-ready outputs.

  • CRF/eCRF design & database build
  • Data cleaning, coding & query management
  • Statistical analysis plans (SAP) & TLFs
  • CDISC (SDTM/ADaM) datasets

Regulatory Affairs

Navigate approvals with confidence across major regulatory authorities.

  • IND/CTA & ethics committee submissions
  • Regulatory strategy & agency interactions
  • GCP compliance & audit readiness
  • Dossier preparation & lifecycle management

Medical Writing

Clear, accurate scientific documents that meet regulatory standards.

  • Protocols & investigator brochures
  • Clinical study reports (CSRs)
  • Manuscripts, abstracts & posters
  • Patient-facing & informed consent documents

Training & Consulting

Build capability inside your team with practical, GCP-grounded training.

  • GCP & regulatory training programs
  • SOP development & quality systems
  • Clinical research career workshops
  • Advisory for startups & academic sponsors

How we work

A transparent, milestone-driven engagement โ€” you always know where your study stands.

PHASE 01

Discover

We map your study goals, timelines, budget, and regulatory pathway.

PHASE 02

Design

Protocol, data, and operational plans built for quality and speed.

PHASE 03

Deliver

Execution with proactive monitoring, risk flags, and weekly reporting.

PHASE 04

Defend

Audit-ready documentation and submission support through approval.

Built for the sponsors who need it most right now โ€” first studies, early-stage teams, and timelines with no room for error.

About us

Pathway Clinical Solutions is a clinical research services company built on a simple idea: every trial needs a clear, well-marked path from protocol to approval โ€” rigorous science, honest communication, and uncompromising compliance at every step. Our team brings together experienced clinical research professionals across trial operations, biostatistics, regulatory affairs, and medical writing.

We work as an extension of your team, whether you're a biotech running your first study, an academic investigator preparing a submission, or an established sponsor who needs reliable execution. Every engagement gets senior attention, transparent reporting, and documentation you can defend in any audit.

Why teams choose Pathway

A clear, well-marked route from protocol to approval โ€” and it shows in how we run studies.

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Compliance-first

ICH-GCP baked into every SOP, from site initiation to database lock.

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Right-sized & responsive

Senior attention on every project โ€” no handing your study to the B team.

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Data you can defend

Clean, traceable, CDISC-compliant data ready for regulatory scrutiny.

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Built for cross-region trials

Processes designed to handle multiple regulatory authorities and multicenter studies from the start.

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Radical transparency

Weekly dashboards and honest risk reporting โ€” no surprises at milestones.

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We build capability

Training programs that leave your team stronger than we found it.

Frequently asked questions

What types of sponsors do you work with?

We support pharmaceutical and biotech companies, medical device manufacturers, academic investigators, and hospital research teams โ€” from first-in-human studies to post-marketing surveillance.

Can you take over a study that's already running?

Yes. We regularly perform rescue work: monitoring backlog clearance, data cleaning, and getting delayed studies back on timeline.

Do you offer standalone services or only full-service packages?

Both. Engage us for a single deliverable (like a CSR or SAP) or for end-to-end trial management.

How do you price your engagements?

Fixed-fee for defined deliverables, milestone-based for full studies. Every proposal includes a transparent cost breakdown.

Let's talk about your study

Tell us where you are in your clinical journey and we'll respond within one business day.

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Office
108, L Block, 1st Floor,
Sri Ganganagar โ€“ 335001,
Rajasthan, India