Training

If you have a urgent need for training in any aspect of the clinical research, we will guide you on the appropriate path for Global and Federal compliance involving all processes and procedures.

We have been training both newcomers as well as seasoned individuals to make the best use of time and planning, for not only monitoring visits, but report writing and timely document maintenance.

We utilize a variety of tools including prepared slides, discussions, practical examples and videos.

Our training teams are comprehensive, current and immensely practical with a hands on approach, while keeping a steadfast focus to all regulatory and protocol driven requirements.

• 21CFR 11, 50, 54, 56, 312, 314 integrated with The CFR
• ICH-GCP E6 R2 (E6R3 draft version endorsed on 19May2023) pending update for final version.
• ICH Harmonization Efficacy Guidelines: Quality/Safety/Efficacy/Multidisciplinary
• History & Overview of Clinical Research
• Evolution of ICH-GCP:
• Data Collection & CRF Completion: ALCOA + C
• Clinical Trial Design and Endpoints for Success Objective
• Protocol & Amendments [ICH-GCP Guidelines Section 6]
• Investigator's Brochure [ICH-GCP Guidelines Section 7]
• Essential Documents in Clinical Trials: How, What, Where, When, and Why
• Role and responsibilities of Research team (DOA Log)
• Data Manager Responsibilities and Team Expectations
• Time Management: Study Timelines and Deadlines
• Central File: Reconciliation to Investigator Site File per ICHE6, Section 8
• Code of Federal Regulations directly applicable to clinical research site
• Audit Preparation from study planning, through to closure
• Preparation of PSV, SIV, IMV & COV. What NOT to forget !
• Roles & Responsibilities of Sponsor, Investigator & Monitors (21CFR312)
• Roles and Responsibilities of Investigational Review Board
• Roles & Responsibilities of Site Study Team on the Delegation Log
• Inform Consent process and documentation
• Monitoring in Clinical Trials: Monitoring Plan Adherence
• Uniformity and Contemporaneous Data Collections

Once these procedures are well understood and implemented, repeating the plan at every visit, will dramatically decrease the time spent on routine procedure checks as well as regulatory upkeep.

Employing the use of a draft agenda at every visit, provides the framework for the follow up letter as well as the platform for future activities

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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