turning operational obstacles into operational success

Quality Management

Let us drive efficiency and quality in your clinical research project.

TMF Management

Let us take the stress out of TMF management.

Regulatory Readiness

Let us ensure your organization is inspection ready at all times.

GCP Audits

TMF Audits

Investigator Site Audits

CRO Audits

Vendor Audits

Sponsor Services

Inspection Readiness

Process Mapping

Clinical Data Management

Forms Development

Staff Training

Site Operations

Job Descriptions

Staff Orientation

Study Preparation

Standard Operating Producures

Implemenation of Formaal Training Program

Implementation of Clinical Research

Team Meeting Management

CPU Operations

Training

Overview Clinical Practices

Investigator Role Instruction

Subject Protection Guidelines

Source Documentation

Study Coordination

General Orientation

QUALITY MANAGEMENT SYSTEMS

A Quality Management System is the cornerstone of a clinical drug development program. STM Biomedical is the solution to all of your quality systems needs.

eTMF MANAGEMENT

We help your organization harness the power of an eTMF to drive quality and ensure inspection readiness. We offer strategies for implementing a successful eTMF system.

FDA INSPECTION READINESS

STM Biomedical has extensive experience in preparing organizations for regulatory inspection. We assist our clients in preparing for the inspection, managing the inspection, and responding to regulatory findings.