Resource centre

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.

 

Regulatory writing

Developing regulatory documents that adhere to ICH guidelines and conform to requirements for e-submission/document management systems such as DocuBridge® or Documentum® can place a burden on company resources.

We have provided here some example document templates that you are free to download and use.

Contact us if there are any templates you need.

 

 

Medical education and strategic communications

We have found that we can cut down on review cycles and deliver documents that better fulfil our clients' expectations and requirements by using a manuscript briefing document. 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.

 

 

Clinical study management policies and SOPs

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. Please find below some examples of SOPs that we have developed. The SOP on 'Production, Review and Approval of Standard Operating Procedures' is available to download opposite. Please feel free to contact us if you would like copies of any other documents.

  • 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

 

 

FYI archive – our regular online magazine

Our news service, FYI, brings you straightforward information on regulatory and pharma activity. It will keep you up to date with news and opinion from the world of medical research including events, grants, corporate restructures and research opportunities. Currently reaching more than 20,000 academics, industry and healthcare professionals you may want to suggest a future topic to be impartially reviewed.

FYI News - Science and industry news

 

 
 

t: + 44 (0)20 8332 2588
f: +44 (0)70 4306 5098
e: info@niche.org.uk

Useful links
Privacy policy