Biometric Consultants to the Pharmaceutical and Biotech Industries
Working with companies to ensure successful clinical trial execution
Quality
Quality is at the core of what we do. This is achieved by open and consistent communication, consistency, verification and validation.
Understanding
We want you to understand all aspects of your clinical trial. This includes (but may not be limited to) study design, study execution and study analysis.
We have open communication with you about the various study documents (protocol, electronic case report form, data management plan, data transfer specifications, statistical analysis plans, …) to ensure that we are all in agreement and everybody understands the details and expectations.
We provide summary reports throughout the course of the study. These summary provide study execution details and data summaries to allow you to understand study progress.
We provide analysis data and outputs to you in multiple formats throughout the course of the study to ensure that you understand the results and analyses performed.
Training
We want you to understand all aspects of your clinical trial. We are pleased to provide training, as necessary, to achieve this goal. We encourage our clients to allow us to provide them the information necessary to understand the various aspects of EDC Support, Data Management and Biostatistics.
Enhancing
Our purpose is to enhance client’s expertise in the EDC support, Data Management and Biostatistics functions.
Reliability
We strive to be a consistent and reliable resource to our clients.
Contact Us
10534 Royal Cypress Way
Orlando, FL 32836
ken@homerbiometrics.com
(407) 279-9345
Services Provided
EDC Support
Help choose and manage the CTMS, eTMF, EDC and IWRS vendor.
Create / Review the CRFs and other documentation required to program the EDC system.
Program / Review the EDC system.
Provide ongoing EDC support through the course of the trial (adding users, answering user’s questions, resetting passwords, ensuring that the system is operating as intended, interact with the system provider to address any issues that arise during the conduct of the trial, …)
Data Management
Create / Review CRF Guidelines.
Create / Review Data Management Plans.
Create / Review Data Transfer Specifications
Assist in the management of data from external vendors.
Generate data listings and patient profiles.
Review subject’s data to ensure accuracy, consistency and completeness.
Issue and resolve queries.
Perform / Manage database lock activities.
Support for Data Safety Monitoring Boards.
Support annual IND Updates.
Biostatistics
Create Statistical Analysis Plans.
Create Ad hoc / Post hoc Analysis Plans.
Document exploratory analyses.
Generate Analysis Datasets.
Create SDTM / ADaM submission datasets with corresponding documentation.
Create Tables, Listings and Figures to support comprehensive study reports.
Interact with the medical writer to generate the comprehensive study report.
Perform exploratory analyses.
Assist in the creation of presentations and abstracts.
Creation / Review of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) outputs and reports.
“If you want to go fast, go alone. If you want to go far, go together.”
– African Proverb