Operations Consulting
We Build the Foundation Your
Clinical Trials Need
From first assessment to first patient, we help clinical research sites launch, scale, and sustain operational excellence.
Why Operations Consulting?
Launching a clinical research site is not just about finding a PI and signing a contract. It requires a comprehensive operational framework — from compliant SOPs and trained staff to GCP-ready workspaces and efficient data management systems.
Most sites learn this the hard way: through audit findings, enrollment delays, and sponsor frustration. AnnMar Consulting exists to prevent that. We bring years of hands-on clinical research experience to help you build it right the first time.
Whether you are a small biotech launching your first trial or an established site expanding into new therapeutic areas, our consultative approach ensures your operations meet the highest standards of compliance, efficiency, and quality.
Our Consulting Services
Comprehensive support for every stage of site operations
Site Readiness & Startup
We assess and prepare your site to meet operational and regulatory standards required for clinical trials. From workspace preparation to GCP compliance, we ensure your site is trial-ready.
SOP Development
We create standardized procedures for key processes including informed consent, safety reporting, staff training, data management, and essential document collection.
Quality Assurance
We audit and refine your operational procedures to meet required standards, ensuring your site passes sponsor audits and FDA inspections with confidence.
Regulatory Affairs & GCP Compliance
We ensure adherence to evolving regulations and ICH E6(R2) guidelines, providing training and compliance frameworks that keep your site current.
PI Acquisition Support
We assist in securing a Principal Investigator with the necessary research experience and medical licensure to oversee your clinical trials.
Team Assembly & Training
We advise on hiring skilled research teams — CRCs, regulatory specialists, data managers — and secure essential GCP training for every team member.
Contract Negotiation
We support the review and execution of Clinical Trial Agreements (CTAs), helping you negotiate budgets and manage sponsor relationships.
Feasibility Analysis
We evaluate your site's ability to execute proposed clinical trials by assessing costs, timelines, patient populations, and operational readiness.
How We Work
A phased approach to building compliant, efficient research operations
Foundational Assessment
We assess your current operations, identify gaps, and define the essential staff, systems, and SOPs needed to run clinical trials effectively.
Infrastructure Build-Out
We develop your SOPs, prepare your workspace to GCP standards, secure necessary training, and establish your regulatory framework.
Trial Acquisition & Launch
We help you connect with sponsors and CROs, conduct feasibility analyses, negotiate CTAs, and assemble your research team for day one.
Ongoing Optimization
We provide continued support through operational audits, compliance monitoring, recruitment for growth, and performance optimization.
Who We Work With
Small Biotechs
First-time trial sponsors who need expert guidance on site selection, setup, and regulatory requirements.
Emerging Research Sites
New sites launching clinical research operations and needing a comprehensive startup roadmap.
Established Sites Scaling Up
Existing sites adding new therapeutic areas, expanding capacity, or preparing for complex Phase II/III trials.
Need Talent Too?
Our recruitment arm places GCP-verified clinical research professionals into the sites we help build. When we consult on your operations, we already know exactly who will thrive on your team.
Start Your Site Readiness Assessment
Tell us about your site, your trials, and your operational challenges. We will design a consulting engagement tailored to your needs.