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CRO-Based Medical Writing

Where clinical evidence becomes
submission-ready writing.

CRO-Based Medical Writing Company

Research with Purpose. Writing with Precision.

About Famorcr

A CRO-based medical writing practice, built on editorial rigor.

Famorcr — Famor Clinical Research Solutions — was launched on 15 July 2026 to give pharmaceutical, biotech and clinical research organisations a dedicated medical writing partner: one that treats every document as both a scientific record and a regulatory instrument.

Trademark Registered LLP Registered Startup India Recognised MSME Registered ISO 9001:2015 Certified · UKAS Accredited MCA Registered

Scope: Clinical Research, Clinical Trial Management, Pharmacovigilance, Medical Writing, Regulatory Consulting, Data Management, Biostatistics and Allied Healthcare Research Services.

We work across the full regulatory and clinical writing lifecycle — from early protocol drafting through clinical study reports, manuscripts and submission-ready documentation. Every deliverable passes through a structured editorial process: medical accuracy, regulatory compliance, and language precision, checked in that order.

Our writers and reviewers work as an extended, globally distributed team, so client engagements can draw on therapeutic-area expertise and regulatory-region knowledge as each project needs it, without the overhead of a single in-house department.

2026Founded
CROWriting model
GlobalClient reach

Our Mission

To deliver scientifically rigorous, regulatory-compliant medical and clinical writing that moves research toward real-world impact — with precision, integrity and consistency at every stage.

Our Vision

To be a globally trusted medical writing partner for pharmaceutical, biotech and CRO organisations — recognised for research-grade quality, ethical rigor and dependable delivery across the clinical and regulatory writing lifecycle.

Our Aim

To become the first-call medical writing partner for companies entering new regulatory markets — pairing therapeutic-area depth with documentation that clears review on the first pass.

Services

Medical writing and CRO documentation, end to end.

Every service is delivered against ICH-GCP, GPP3 and journal- or agency-specific formatting standards, with a dedicated reviewer on every document.

What We DoWrite

Protocols, CSRs, manuscripts, safety and submission documents drafted by subject-matter writers, not generalists.

What We DoReview

Independent medical, regulatory and language review on every document before it reaches you.

What We DoComply

Every deliverable checked against ICH-GCP, GPP3 and the target region's regulatory format.

What We DoDeliver

Tracked versions, clear turnaround windows and a single point of contact from brief to sign-off.

Clinical Study Reports

ICH E3-compliant CSRs, from synopsis to full report, aligned with underlying protocols and statistical outputs.

Clinical Trial Protocols

Study-design protocols, synopses and amendments for Phase I–IV trials, written for site and regulator readiness.

Regulatory Submissions

CTD/eCTD modules, IND/NDA/BLA documentation and agency-response writing for global regulatory filings.

Medical Manuscripts

Journal-ready manuscripts, abstracts and posters written to GPP3 and target-journal guidelines.

Pharmacovigilance Writing

PSURs, DSURs, case narratives and aggregate safety reports prepared to global PV reporting standards.

Investigator Brochures

Living IBs kept current with emerging safety and efficacy data across the life of a trial.

Informed Consent & Patient Materials

Plain-language ICFs and patient-facing documents that stay compliant without losing clarity.

Systematic Reviews & Meta-Analyses

PRISMA-aligned literature reviews and evidence synthesis for publication or submission support.

SOPs & Quality Documentation

Standard operating procedures and quality-system documents built for audit readiness.

How We Do It

A fixed process, applied to every document.

The same five stages run on every engagement, regardless of document type — so quality doesn't depend on which writer picks up the brief.

01

Discovery & Scoping

Requirements, therapeutic area, target regulator or journal, and timelines confirmed before any drafting starts.

02

Assignment

Matched to writers and reviewers with the relevant therapeutic-area and regulatory-region experience.

03

Drafting

Structured writing against source data, protocol and the applicable regulatory or journal guidance.

04

Medical & Regulatory Review

Independent review for medical accuracy, compliance and internal consistency before it reaches you.

05

Delivery & Revision

Tracked-changes delivery, a defined revision window, and sign-off with a single point of contact.

Protocols

Protocol writing, from first draft to final amendment.

Protocol work is where a trial's scientific and regulatory logic is set — our process keeps that logic traceable through every revision.

01

Protocol Synopsis & Full Protocol Development

Phase I–IV clinical trial protocols built from objectives and endpoints through to full ICH M11-aligned study documents.

02

Statistical Analysis Plan Support

SAP drafting and cross-checking against protocol endpoints, so analysis and design stay aligned.

03

Protocol Amendments & Deviation Documentation

Version-controlled amendment writing with clear rationale and impact assessment for each change.

04

ICH-GCP & Regulatory Compliance Review

Independent review of draft protocols against ICH-GCP and region-specific regulatory expectations.

05

Site-Ready Protocol Localisation

Formatting and language adaptation so protocols are ready for multi-site and multi-region rollout.

Why Famorcr

Senior-level writing, without agency overhead.

We operate as a focused medical writing practice, not a multi-layered agency — so engagement budgets go toward the writers and reviewers actually working on your documents, not toward extra management layers.

That structure keeps our pricing competitive against larger CROs and standalone writing agencies, without cutting corners on ICH-GCP rigor, review depth, or turnaround discipline.

Lean team structure

No layered account-management overhead — budget is spent on writing and review, not process.

Direct writer access

You work directly with the writer and reviewer on your document, not a relay of account managers.

Transparent, scoped pricing

Quoted per document or engagement upfront, so costs are clear before drafting begins.

Resources

A globally experienced writing & review network.

Engagements are staffed against therapeutic area and regulatory region, drawing on an extended network of medical writers, regulatory specialists and reviewers.

MW

Senior Medical Writers

PharmD / PhD, CSR & manuscript lead
12+ yrsIndia · US
RA

Regulatory Affairs Specialists

CTD/eCTD & submission strategy
10+ yrsEU · APAC
CR

Clinical Research Associates

Protocol & site documentation
8+ yrsIndia · MEA
BS

Biostatisticians

SAP & statistical reporting support
9+ yrsUS · India
PV

Pharmacovigilance Experts

Safety narratives & aggregate reports
11+ yrsEU · India
QA

Quality & Compliance Reviewers

ICH-GCP & audit-readiness review
10+ yrsGlobal
Roles above reflect the disciplines represented across our writing and review network for client engagements. Project-specific resumes and writer credentials are shared under NDA as part of onboarding.
About Famorcr
A CRO-based medical writing company built to serve pharmaceutical, biotech and clinical research clients worldwide. Our team works across the regulatory writing lifecycle — from clinical study reports and protocols to manuscripts and submission documents — with a research-grade editorial process. We're onboarding our first partners now; full project details and case studies will be published here as the site launches.
🇮🇳 Headquarters
Panthaneer Apt, Ghola Check Post, Sodepur,
Kolkata – 700111, North 24 Pgs, West Bengal, India