Medical Writing
During the course of your project, you may require documents, guidelines and services that are concise, accurate and comprehensive, all of which we can provide within your timeline. These may include, but are not limited to the list below.
Our highly experienced medical writers have worked in almost all therapeutic areas and indications as well as FDA mentoring and preparation for IND and NDA submissions.
Our writers are meticulous, organized and tenacious with decades of experience in medicine and research. Every project bears our promised signature before final approval.
At CPR, our writers are highly effective at what they know and how they write, which is reflected in the content, style and versatility of each composition.
All projects are reviewed and co-edited before presenting to the client. Rigorous collaboration among specialists, is our policy.
Internal
- Abstracts and Scientific Publications
- Annual Study Reports
- Audit Plans for Data Compliance & PI Oversight
- Audits for site staff and EDC, Labs & Equipment
- CAPA Development Annotations and proposal Guidelines
- Clinical Study Reports: ICH E3: ClinicalTrials.gov
- Data Management Plan and Manuel
- DM Guidebook with Updates
- Informed Consent Forms with Amendment changes
- 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
- Monitoring Plan formatting and creation
- Organizational Plans – All therapeutic Areas & Indications
- Processes & Procedures Compliance Manuals
- Protocol and Amendments with edits
- QA Oversight of IRB communications and updates
- QA Proposal Consideration
- RACI Matrix creation
- 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
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