Contract Research Organization · New Jersey
Method365 is a 100% woman-owned CRO supporting sponsors and investigator sites across clinical operations, project management, site management, GxP compliance, audit readiness and clinical supply — backed by more than 20 years inside leading CROs and pharmaceutical companies.
Method365
CLINICAL · CONSULTING
100%
Woman-owned business
20+ years
Experience at leading CROs and pharma
Est. 2025
Headquartered in New Jersey
5 regions
USA, Europe, India, Sri Lanka, Australia
ICH-GCP
Quality-first delivery
What we do
Engage us for a single function or an integrated program. Each service is delivered by senior professionals who have done the work inside sponsors and CROs — and who know what regulators and auditors look for.
End-to-end support
From the first feasibility question to the final inspection, Method365 brings the right expertise to each stage of your study.
Protocol review, country and site feasibility, budgets, supply strategy.
Regulatory and ethics submissions, contracts, essential documents, site initiation.
Recruitment plans, site support, enrollment tracking and course-correction.
Monitoring oversight, vendor management, IP resupply, issue escalation.
GxP oversight, deviation and CAPA management, TMF completeness.
Site close-out, IP reconciliation, archiving and inspection readiness.
Global coverage
We support sponsors and sites in the United States, Europe, India, Sri Lanka and Australia — with working knowledge of each region’s regulatory pathway, ethics review and site landscape.
United States
FDA
IND studies under 21 CFR Parts 312, 50 and 56; electronic records under Part 11; IRB oversight.
Europe
EMA & national authorities
EU Clinical Trials Regulation (EU) No 536/2014 and CTIS submissions; MHRA for the UK.
India
CDSCO
New Drugs and Clinical Trials Rules, 2019; ethics committee approval; CTRI registration.
Sri Lanka
NMRA
Review by the NMRA Subcommittee on Clinical Trials; ethics approval; SLCTR registration.
Australia
TGA
CTN and CTA schemes; HREC review under the NHMRC National Statement.
Across every region, our work is grounded in ICH E6(R3) Good Clinical Practice and the applicable local requirements.
Our approach
Our name is our promise: a disciplined, repeatable method applied with the consistency and availability your program deserves.
01
We start by understanding your protocol, team, risks and regulatory landscape.
02
A clear, right-sized plan with owners, milestones and quality checkpoints.
03
Senior-led delivery with transparent reporting and early escalation of issues.
04
Knowledge transfer and compliant documentation that outlast our engagement.
About Method365
Method365 was established in 2025, carrying the essence of more than two decades spent with leading contract research organizations and pharmaceutical companies. We bring that depth to every engagement — with the attention and agility of an independent firm.
We are a 100% woman-owned business, based in New Jersey — the healthcare innovation chest of the world, home to many of the companies shaping modern medicine.
“Patients are waiting on every study we touch. Our job is to remove friction, protect quality and keep the work moving.”
[FOUNDER NAME], Founder & Principal, Method365
Who we serve
Biotech, pharmaceutical and medical device sponsors, CROs and research sites
How we engage
Project-based, functional outsourcing or embedded consultants
Contact
Tell us where you are and what you need. We’ll respond within one business day to set up an initial conversation.
Once your email is sent, a member of the Method365 team will reply within one business day. If no email app opened, write to us directly at info@method365.com.