Resolution has extensive experience in writing and reviewing scientific documentation and can help remove administrative bottlenecks regarding Reports, Protocols, SOPs, etc.  Whether you want these to be written for you, to have existing materials reviewed for completeness, accuracy and compliance with your requirements or simply to have translated documentation reviewed for clarity and sense, Resolution can meet your needs.

 

In addition, if a retrospective expert technical review of analytical data is required to decide if analytical data and results are acceptable or if it is necessary to conduct a costly repeat study, (eg as a result of receipt of the US FDA letter of 10 Jan 2007 (see http://www.fda.gov/cder/news/pharmaco_studies/default.htm) concerning certain studies in support of Approved and Pending Abbreviated ANDAs, Resolution has the experience to satisfy the FDA's option for an independent expert audit (see the Analytical Data Review  page). 

 

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• Removes bottlenecks

• Saves time

• All writing is in concise, unambiguous English

The services described focus on reports, protocols and SOPs, but can be applied to any scientific writing, including data summaries and scientific papers.

Scientific Writing
Often everything required to compile a critical document is known or available, but progress is blocked because this final step does not happen quickly enough.  This most commonly applies to reports (all of the data are available but pulling the report together can take weeks or even months), but it also applies to protocols and SOPs.  Delayed protocols affect study start dates, overdue reports affect planning decisions and missing SOPs impact on Quality, all of which will have a negative impact on programme schedules.  Resolution can work with you to ensure these critical documents are available when they are required.

Reviewing Reports
Once a draft report is submitted from your CRO, it has to be reviewed to ensure the data and conclusions are complete and presented to your satisfaction and that the overall style and Quality meet your requirements.  This time-consuming process may conflict with other critical demands on your time.  Talk to Resolution, explain your requirements and let us handle this process for you.

Occasionally there may be a requirement to conduct an expert technical review of the analytical raw data used to generate the report.  Resolution has the experience and expertise to undertake this function on your behalf (see Analytical Data Review ).

Writing Summaries 
Resolution can prepare summaries covering individual reports or on a series of reports from a programme of studies.  This can be useful, particularly regarding analytical methodology when support for programmes has come from more than one laboratory using more than one method over a period of time.

Checking Translated Documents
If your reports, protocols or SOPs have been translated into English from another language, ask Resolution to check that these make sense and that the meanings are clear.