Vantage BioTrials’ Project Managers are the glue that bind relationships with Sponsors. Our PMs break down barriers to allow other team members to innovate new ways to do things & empower them to share ideas. They are experts in implementing risk mitigation through the use of Quality by Design (QbD) methodologies by ensuring adequate oversight of global clinical conduct/site management. They are essential to tracking projects and ensuring that milestones are met through the review of Key Performance Indicators (KPIs), such as: • Enrollment • Ethics submissions/approvals • Monitoring visits and reports • Milestone • Budgets

Vantage BioTrials’ Project Managers are the glue that bind relationships with Sponsors.

Our PMs break down barriers to allow other team members to innovate new ways to do things & empower them to share ideas.

They are experts in implementing risk mitigation through the use of Quality by Design (QbD) methodologies by ensuring adequate oversight of global clinical conduct/site management. 

They are essential to tracking projects and ensuring that milestones are met through the review of Key Performance Indicators (KPIs), such as:

• Enrollment
• Ethics submissions/approvals
• Monitoring visits and reports
• Milestone
• Budgets

Vantage BioTrials’ monitors are trained not to only to monitor, but to also manage sites.

They interpret the metrics, performance indicators, and trends that emerge from a combination of on-site and centralized monitoring that will in-turn ensure proactive decision making and interventions.

They guarantee the continuous flow of study data that is being monitored for trends to enable real-time decision making and action.

Always rest assured and have a piece of mind that our monitors are monitoring data on your behalf.

Our Medical Monitors can help design and/or support your next clinical trial.

They can provide an overall clinical perspective as it relates to your business strategy, Product Development Plans, development of Target Product Profile/s, CMC activities, regulatory strategy and Clinical Development Plans.

Services offered during a conduct of a clinical trial include:

• 24/7 Medical monitoring

• Processing and evaluating SAEs/UADEs

• Preparing and writing SAEs/UADEs case narratives

• Safety data review and submission of safety reports to Regulatory Authorities

• Medical data coding consistency review

• Scientific and medical review of Investigational Brochures, Clinical Study Reports, Protocols and Clinical Development Plans

• Preparation of Safety Alert Reports Including Narrative (CIOMS and MedWatch)

• Preparation and review of Data Safety Monitoring Board (DSMB) Charter

• Management of DSMB

The quality of writing and content is key to the submission of any clinical trial.
We offer various medical writing services that cater to your needs. The categories and services include:

Medical and Regulatory:

• Protocols

• Clinical study reports

• Patient narratives

• Investigator’s brochures

• Product monographs

• Clinical trial applications

• New drug submissions

Journalistic Writing:

• Articles for trade and consumer magazines

• Slideshows

• Booklets, annual reports, press releases

Conference Coverage:

• Abstracts

• Slide presentations

• Posters

• Proceedings Scientific

Writing:

• Grant proposals

• Literature search

• Research papers

• Course notes

• Book chapters

Specializing in Clinical Statistical Analysis, Clinical Trial Design and Data management of clinical research for pharmaceutical, biotechnology & medical device companies, our Data Management/Stats partners bring unique expertise, flexibility and affordability of services that is expected by our Sponsors.

Sponsors will benefit from our customer focused team and the qualities that significantly differentiate us include:

Statistical Consulting:

• Delivering objective perspectives.

• Protocol design & review, sample size calculations, statistical methodologies, Bayesian analysis, data quality oversight, development of protocols and Statistical Analysis Plans (SAPs).

Statistical Services:

• Delivering vital statistical strategy to help mitigate risks during product development.

Clinical Trial Design:

• Providing tailored clinical trial design specific to research goals.

Clinical Data Management: 

• Committed to customizing data solutions that emphasize cost, efficiency, data integrity & accuracy.

Vantage BioTrials’ Clinical Trial Management System (CTMS) allows you real-time access to information regarding the status of each trial. It gives project owners, stakeholders, and leadership a robust, real-time view into the status of top KPIs, critical trends, and summary/financial reports.

Key features of the CTMS include:

• Web based system – available anytime/anywhere • Validated system

• Customized to meet your requirements

• Highly secure system via SSL • Fully Functional

• Key Study Information and metrics (e.g. • Enrollment and SAE Tracking; Managing Monitoring Reports, Gantt Chart, etc.)

• Dashboards

“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution.” – William A. Foster

Quality is one of Vantage BioTrials’ most important elements when managing a clinical trial or performing quality assurance audits of investigational sites or Contract Research Organizations.

Here’s a list of what we can do for you to help maintain Quality for your studies:

• Generate audit reports and review for accuracy, clarity and completeness.

• Ensure that impact/validity assessments are clearly written and, where appropriate, support the facts.

• Manage event investigation process and ensure regulatory compliance for all studies reviewed.

• Conduct general inspections/monitoring of Phase I-IV studies in compliance to Protocols, SOPs, GLPs, GCPs and generally accepted scientific principles.

• Audit raw data records for completeness and within compliance to Protocols, SOPs, GLPs, GCPs, 21 CFR Part 11 and generally accepted scientific principles.

• Audit of reports to ensure that the results incorporated accurately reflect the raw data. Gap analysis of processes and organization

• Vendor audits

• Quality System Optimization including development of quality manuals and policies, SOPs, work instructions, QA processes, training, and regulatory inspection readiness programs.

Unfortunately it is a fact of life in clinical research to encounter issues that negatively affect or hinder the progress of your studies, especially with problematic investigative sites or poor quality of work provided by other CROs.

With our experience handling complicated trials, our Sponsors come to us to implement our Strategic Working Action Teams (SWAT) into a cohesive unit to address the issues and efficiently rescue your study from disastrous consequences. Our SWAT team is comprised of a small number of carefully chosen experts (including at least one senior project manager and clinical monitor) who come up with action plans to get your study back on the right track and on the road to a successful conclusion.