Monitoring & Reclamation

Our highly experienced and safety driven professionals will provide superior and exceptional review of study records resulting in clean data.

In order to fulfill all local, state and federal regulations, our team ensures a constant vigilance over the data so that it is complete and accurate, attributable and contemporaneous, without exception.

It is with these superior qualities and objectives that our team delivers outstanding and reliable results.

1. 100% SDV, for every datapoint
2. Risk based monitoring as required/expected
3. Patient safety and enrollment
4. Reclaim previously monitored data
5. Laboratory requirements and communications
6. Multiple department interactions and consistency
7. Regulatory compliance for all protocols and amendments
8. Contract fulfilment between sponsor and CRO
9. GCP and QA assurance
10. Database auditing and fulfillment
11. Specific needs for any project

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
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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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