Useful documents and supporting materials that we
have provided to help you
While providing our regulatory writing, communication and project management services we have often been asked by our clients to develop materials such as document templates or guidance that can help simplify the process of delivery or promote wider understanding. We would like to share some of these products with you in the hope you find them useful.
By using a manuscript briefing document, we have effectively reduced review cycles and deliver documents that more in tune with our clients' expectations and requirements. Please feel free to download and use our briefing template.
We have also provided an editorial mark-up guide as use of clearly understood and consistent editorial mark-up facilitates the review process. Similarly, deciding on the poster format that best displays your data can be complicated.
We have provided here two flexible examples of poster templates we have used successfully in the past. Also included is a selection of other poster designs you may want to consider.
Contact us if there are any regulatory document templates you need support with.
In start-up biotech and smaller pharmaceutical companies, priority is usually placed on getting to FTIH trials or 'starting the next study'. The importance of clearly defining and properly maintaining Standard Operating Procedures (SOPs) can easily be overlooked. Free to download below is a template for your SOP #1, 'Production, Review and Approval of Standard Operating Procedures.' Contact us if you are looking for inspiration for any other policy documents or processes, such as:
- Training for Employees Involved in the Performance of Clinical Trials
- Monitoring of Clinical Trials
- Medicinal Product Management
- Compilation and Maintenance of Essential Trial Master File Documents
- Preparation of Protocols and Amendments
- Writing and production of regulatory documents
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