Medical Writing

This is what we can provide for your writing assignment requirements:

Internal

• Monitoring Plan formatting and creation
• Data Management Plan and Manuel
• Clinical Study Reports: ICH E3: ClinicalTrials.gov
• Organizational Plans – All therapeutic Areas & Indications
• Audit Plans for Data Compliance & PI Oversight
• Audits for site staff and EDC, Labs & Equipment
• CAPA Development Annotations and proposed Guidelines
• Data Management Plan and Manuel
• DM Guidebook with Updates
• ICF & Amendments Development
• ICF Process Document Form
• Interim analysis event planning for study
• Investigational Brochure development and formatting
• Investigational Product Manual and Accountability
• Investigational Product Packaging Manual
• Laboratory Manual development and Communication
• Abstracts and Scientific Publications
• Processes & Procedures Compliance Manuals
• Protocol and Amendments with edits
• QA Oversight of IRB communications and updates
• QA Proposal Consideration
• RACI Matrix design and guideline reference
• Report Templates: PSV, SIV, IMV, COV, QA
• Report Template Annotations
• Site management PM
• START UP – All Therapeutic areas & All Communications
• Standard Operating Procedure development
• Vendor Identification Requirements & Questionnaires
• Vendor compliance Audit Annotation
• Informed Consent Forms
• Case Report Forms Composition

External

• Contract Compliance Audits between Sponsor and CRO
• Employee Management Review Development
• Investigational New Drug (IND) Discovery research and assessment
• New Drug Application (NDA) Analysis and submission
• PM Plan Audit for project oversight
• Sponsor and CRO audit Development

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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