Weekly internal study meetings – we a checking sites` metrics: enrollment status, query status, action items status, PD status – we excluding the most common reason of sites ineffectiveness – Gaps in an enrollment, overdue queries and action items, lack of protocol compliance.

Fast Track Agreements Process©
Trial guidelines developing:
Clinical Monitoring Plan
Project Risk Management Plan
Safety Management Plan
Protocol Deviation Plan
Study Communication Plan
Data Management Plan
Study Logs
Patients` Worksheets

At Zodiac Trials, we understand the critical role that bioequivalence studies play in the successful development and registration of generic and innovative pharmaceutical products. Our specialized services are designed to provide you with the comprehensive support you need to navigate the complexities of regulatory requirements and ensure your product's success in the marketplace.

Pre synopsis and synopsis preparation
Study protocol developing
Clinical Study Report preparation

Data Management Plan
Data Validation Plan
Medical coding
Database cleaning
Data management
Query management

Study approval obtaining
Correspondence with Authorities
Import export license obtaining

Pharmacovigilance
Safety Management Plan
AE/SAE/SUSAR management
Safety submissions to LECs and Authorities

Onsite monitoring
Remote monitoring
Risk Based Monitoring
Central Monitoring
PD management
Action Items management

Vendor Assessment and Selection procedure
Managing selected vendors, materials and systems for a clinical trial
Full cycle of laboratory management (samples logistic, analyzing, materials shipping)

Co-monitoring
Risk-Based Focus
Internal Audits per SOPs

Sample size calculation
Statistical analysis plan and statistical report preparation