is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Tuesday, November 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).
Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.
Showing posts with label SFP Consulting. Show all posts
Showing posts with label SFP Consulting. Show all posts
Tuesday, October 25, 2011
Tuesday, September 6, 2011
Using Short Style Guides to Harmonize Writers and Improve the Quality of Electronic Submissions
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting and airs on Wednesday, October 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.
In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.
Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors. This miniature version of the style guide can bring disparate groups of writers up to speed quickly and ensure that the most important aspects of the company’s writing style are consistent throughout its documentation. Perhaps most importantly, the critical aspects of template use can be emphasized in this short format to ensure efficient publication of electronic submissions.
In this audio conference, our speaker provides tips and insight on developing and managing the use of short style guides, and how best to use them to improve the quality of your regulatory submissions.
Thursday, July 21, 2011
Optimizing Data Displays for Safety Messaging
is being presented by Dr. Susan Sisk, Principal, SFP Consulting, LLC and airs on Thursday, August 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Many times, tables and listings used for preparing clinical study reports, integrated summaries, and other clinical documents are designed without closely considering how these data displays will be used by the writer and review team to expedite document preparation and support messages about healthcare products. For example, does placebo come first on your tables and, if so, does that mean placebo is first in the text, or are you more interested in the test drug, mentioning placebo in context as a comparator? Or, have you ever written narratives from listings that required you to look up information in dozens of fields and then to do manual calculations to obtain “durations” required by the template, rather than the date-formatted data provided in the displays?
This audio conference presentation is designed to educate and to provoke dialog between statisticians and writers, as well as medical, regulatory, and project managers, with respect to appropriate display of clinical information to expedite document preparation and review.
Many times, tables and listings used for preparing clinical study reports, integrated summaries, and other clinical documents are designed without closely considering how these data displays will be used by the writer and review team to expedite document preparation and support messages about healthcare products. For example, does placebo come first on your tables and, if so, does that mean placebo is first in the text, or are you more interested in the test drug, mentioning placebo in context as a comparator? Or, have you ever written narratives from listings that required you to look up information in dozens of fields and then to do manual calculations to obtain “durations” required by the template, rather than the date-formatted data provided in the displays?
This audio conference presentation is designed to educate and to provoke dialog between statisticians and writers, as well as medical, regulatory, and project managers, with respect to appropriate display of clinical information to expedite document preparation and review.
Friday, May 27, 2011
Choosing and Managing Contract Medical Writers
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Thursday, July 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.
This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.
Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.
Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.
This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.
Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.
Friday, April 29, 2011
Best Practices for Writing Safety Narratives
is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Wednesday, June 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).
Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.
As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).
Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.
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