Auditing

Auditing And Audit Prep

If an auditor calls and you need help, contact us and we will guide you through the critical curves involving Phases I - IV beit For-Cause or surveillance.

A vast array of audits may be performed which will be contracted within the Scope of Work or ad hoc.

• Audit Prep for Any and All Procedures (SOPs), Processes & Policies
• Patient Safety, Documentatio, & Well-Being Assurancen
• Verification of Contractual Fulfillment
• Data Collection and DM Revision
• Timely Query Resolution
• GCP and CFR Compliance
• Investigational Product: Unblinding Execution & Fulfilment
• IT Security Surety
• Laboratory Communication & Compliance
• Manual Completeness and Implementation
• Project Management Review & Restructuring
• SOP Compliance During the Course of the Clinical Trial
• Vendor Custody and Oversight
• Vendor Software Utilization compliance
• Database Integrity Verification
• eDocument Archiving & Organization

We are well aware of corporate customs in clinical research and we excel at navigating the sometimes dangerous twists and turns on the path for an ordered and quantified outcome

We take the anxiety off your shoulders and ensure regulations have been followed to ensure patient safety and the precision of data collection.

Monitoring & Reclaimation

Whether you are in need of a first-time data monitoring team or trying to rescue incomplete data from previous reviewers, we can jump in at any stage and get the job done.

Our inimitable reputation makes us the perfect choice for first time review of data OR as a SWAT Team rescue involving a project in distress.

Our turnaround time will be met masterfully, comprehensively and in compliance with all regulations.

Auditing

Audits should not be an imposition, but the culmination of all your training and experience, that reflect implementation of both FDA regulations and GCP Guidelines.

Even as an avid clinical researcher there will be times when you need support with the planning, preparation and implementation for the Big Day
.
We can prepare you, train you or take over the reins and ensure that your processes, procedures, and data are in audit ready condition.
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Medical Writing

From start-up activities to closing assessments and more, documents, manuals, and guidelines are always in need of creation, revision, and modification.

Our experienced medical writers are effective at what they know and how they write, which is reflected in the content, style and versatility of each composition.

They are meticulous, organized and tenacious with decades of experience in almost all therapeutic areas and indications, as well as FDA mentoring and preparation for IND and NDA submissions.
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Training

Historically speaking, site training tends to be needlessly complex, poorly organized, & unreasonably long, so much is overlooked before long.

We specialize in making training effective and short, with directives as to where to find the detail.

We can help your staff better understand the “required” code of Federal Regulations and the ICH-GCP Guidelines as is required in all phases of Clinical Research

If you give a man a fish, he eats for a day. If you teach that man to fish, he eats for life !!!!.
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