About Us

On a contract basis, Scriptorium specializes in offering the highest quality and timely production of regulatory medical writing and publishing services for the preparation of Clinical study Protocols (CSP), Clinical Study Reports (CSR), Annual Safety Reports (ASR), and Periodic Safety Update Reports (PSUR) for submission in the United States. We also offer clinical abstract, poster, and manuscript writing, preparation and submission services.

Scriptorium currently has contracts in place with a leading medical university in Durham, NC a leading CRO in RTP, NC and a pharmaceutical company in Chapel Hill, NC.

Frank G. Bottone, Jr., Ph.D. founded Scriptorium in 2007 after working with two of the largest CROs in RTP, NC. Frank works as the lead writer or project director for all projects depending on your needs and budget.

Having worked as a regulatory and publications medical writer, Frank is well versed in the terminology, procedures, and environment of medical writing. At the onset of Scriptorium, Dr. Bottone worked as the sole medical writer on all projects. Over time, he has several roles including that of a writer and as a Project Director. During this time, the contract medical writing services model and offerings have continuously increased in scope and this model has proven to be very successful for Scriptorium and our Clients.

Webpage design by Frank G. Bottone, Jr., Ph.D.

Scientific Posters

Corporate Press Releases

Slide decks and Presentations

Pharmaceutical sales training

Clinical study summary

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Manuscripts for English

...and many more confidential documents

 

Regulatory Documents

 

Letters of Intent

 

Clinical Study Protocols

 

Research Grants

 

Product Dossiers

 

Standard Operating Procedures

 

Standard Response Letters

 

Product Inserts

 

Patient Product Inserts