Let’s do the math:
The process of developing drugs that could be of benefit to millions of people is as cost and time-intensive as it is rigorous. Pre-clinical trials can last up to 7 years while research and development (R&D) can take over 10 years and involves a lot of clinical study reports (CSRs). The journey of R&D and obtaining patents for new drugs starts with companies gaining 20-year patents for new drugs. At least 10 of the 20 years are dedicated solely to pre-clinical trials. Companies are, therefore, left with about 9 years to introduce the drug to market and claim market share before competitors come up with generic variations.
The introduction of generic variations of a drug into the market space result in a notable decrease in sales, a factor attributed to the loss of monopoly by the drug company. It is, therefore, important to optimize each stage of the drug’s journey — from discovery & development to its introduction to the market and the exclusivity period.
This optimization includes the efficient generation and management of the plethora of documents or clinical study reports generated at the pre-clinical, clinical, and commercial stages. Any mishap in any of these stages can hurt a drug’s time to market (TTM) because of disapproval.
Windward can step in to make the whole clinical study report generation process error-free, simple, and swift at every stage of drug development (and subsequently decrease the TTM). Your researchers and scientists can create templates within minutes and generate hundreds of such different types of clinical study reports or documents in just a few clicks.
CSR Template creation requires no coding and even an individual can create them right within familiar applications like MS Office with unlimited parameters and tags. One can also import clinical report templates and use them as sub-templates for other documentation purposes. In a nutshell, Windward supports advanced templates for creating clinical study report format in quick time unlike any other document generation product available in the market.
The development of a new drug sees scientists dedicate many years in creating the right blend of biological and chemical substances. This process climaxes in the submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). Subsequent pre-clinical trials can only be undertaken upon FDA approval.
Chemistry and biological tests, animal and laboratory studies, pharmaceutical development tests, and manufacturing test reports are some of the documents that are generated during discovery phases of medicine. For IND submissions to be complete, one needs to compile information on the drug-under-development including the drug’s composition and chemical structure, how constituent compounds have been manufactured, its effects on animals and humans, and any observed or potential side effects.
Managing IND reporting and documentation is important as it allows you to handle the growing number of report volumes efficiently all the while complying with the regulations stipulated by the FDA.
As informed above, Windward can help you handle IND documentation without any errors and in quick time. You can generate these documents in a wide range of formats including PDF, HTML, PPTX, DOCX, and more.
The objective of the pre-clinical phase is to generate relevant IND documents and ensure their submission. The objective of the clinical phase is to advance the process by generating and submitting a New Drug Application (NDA) submissions. This stage of drug development can last over 10 years. Documents developed during this phase are relevant to contract research organizations (CRO), sponsors, enrolled patients, and study sites.
The various details and documents pertaining to the nature of the clinical studies are collated into a Trial Master File (TMF). The efficiency and safety of a new drug are determined in this phase. Data as well as supporting documentation are then submitted in marketing applications by sponsors.
Similar to the pre-clinical phase, the clinical phase requires effective management of documents. This is important not only for meeting the set standards for statutory compliance but for efficient filling, storage, retrieval, and presentation of related documents. FDA clinical study report must be properly generated and managed as they are necessary for the multiple submissions necessary at every stage to achieve quick approvals for the manufacturing and marketing of the product.
Windward can help you generate the clinical trial reports and documents that can include adverse event reports, human subject safety compliance documents among other common technical documents without any errors. You can connect a lot of datasources (over 150!) to your created templates for generating this extensive range of documents and reports during the clinical trials. Moreover, they will all be in compliance with the clinical study report guidelines.
New drugs can find their way into the market upon the FDA’s approval of NDAs submitted. However, communication between the developing companies and the regulatory authorities doesn’t end here. Constant and continued communication between the two is necessary as companies need to continuously submit amendments containing information on any changes in manufacturing, any emerging reports on adverse events and annual compliance reports to the regulatory authorities.
Besides, processes involved in the quality control, sale, manufacturing, and marketing of a new drug will churn numerous documents that need to be submitted to regulatory authorities in a timely and consistent fashion during the commercialization phase. Documents generated in this phase are a result of quality-related processes that inform handling Corrective and Preventive Actions (CAPA), consumer complaints, electronic batch numbers (EBR), reports of adverse events, non-conformance, deviations, and quality audit reports (just to mention a few).
And, Windward is up to this mammoth task as it can automate the document creation process and help you churn out thousands of documents error-free and quick. So your clinical study report submission FDA will be flawless and fast.
As you can see from above, final clinical study report generation is key in all three phases of drug development. Windward helps lab researchers, pharma investigators, and other employees handle the heavy document generation workload effectively and efficiently. It allows big pharma companies and small lab research firms alike to focus more on their core drug development process and improve TTM as a result.
Learn more about Windward on our site, and when you’re ready, try a 14-day trial.
Adds various capabilities such as inequalities,descending sort, joins, and other functions.
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SQL Select Debugger
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Added a Query tab as a field for typing or pasting in a select statement
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All tags using that Data source will be automatically updated with that name.
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New single interface to replace 2 separate dialog boxes
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Displays of all the tags in the template, structured as they are placed in the template. This provides a simple & intuitive way to see the structure of your template. Also provides the capability to go to any tag and/or see the properties of any tag.
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The ability to integrate the Windward Engine into Google’s cloud computing platform for developing and hosting web applications dubbed Google Applications Engine (GAE).
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This new integration will allow for processing of complex scripts and bi-directional text such as Arabic. Your PDF output will be much tighter and more closely match your template, and we’ll be able to respond rapidly to PDF requests and fixes.
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Includes support for new ForEach and slide break handling, table header row repeat across slide breaks, and native Microsoft support for charts and images.
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Tags are color coded in the template by type, making it easy to visually identify them.
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Version 13’s core code has been reworked and optimized to offer a reduced memory footprint, faster PDF generation and full documentation of supported features and limitations in the specifications for DOCX, XLSX and PPTX.
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Documents can include advanced Word image properties such as shadows, borders, and styles.
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Windward has updated HTML output to reflect changing HTML standards.
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Windward now works with a slew of new datasources: MongoDB, JSON, Cassandra, OData, Salesforce.com
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The Generate Code tool in the designer allows you to open an existing template and, with a click of a button, automatically create a window with the code needed to run your current template with all data sources and variables. Simply copy this code and paste into your application's code in the appropriate place. You now have Windward integrated into your application.
You only need to do this once. You do not do this for each template. Instead, where it has explicit files for the template and output, change that to parameters you pass to this code. Same for the parameters passed to Windward. This example uses explicit values to show you what to substitute in where.
Any pivot tables in an XLSX template are carried over to the XLSX output. The ranges in the pivot ranges are adjusted to match the generated output. So your final XLSX will have pivot tables set as expected in the generated file.
This makes creating an XLSX workbook with pivot tables trivial.
In an imported sub-template, if its properties for a style (ex. Normal) differ from the parent template's properties for the style, the use in the sub-template can be set to either use the properties in the sub-template, or the properties in the parent.
You set to retain when you don't want the child template's styling to change when imported. You set to use the parent when you want the styling of the imported template to match the styling in the parent.
Any explicit styling is always retained. This only impacts styling set by styles.
Tags can be placed in text boxes. Including linked text boxes. This gives you the ability to set the text in a textbox from your data.
Tags can be placed in shapes & smart art. This gives you the ability to set the text in a shape from your data.
When generating HTML output, the engine can either write bitmaps as distinct files the generate HTML references, or it can embed the images in the HTML providing a single file for the output.
You can place tags in pretty much any part of a template, including in footnotes & endnotes.
Any parts of a DOCX or XLSX (PowerPoint does not support this) file that are locked in the template, will be locked the same in the output.
If a font used in the template does not exist on the server generating a report, the font to substitute can be specified.
In addition, if a glyph to be rendered does not exist in the font specified, you can specify the replacement font. This can be set distinctly for European, Bi-Directional, and Far East fonts.
If you need this - it's essential. And if you don't need it, it's irrelevant.
Windward enables you to build a document by applying multiple datasources to the template simultaneously. When Windward is merging the data into a template, it processes the template by handling each tag in order, and each tag pulls from different datasources. (As opposed to processing all of one datasource, then processing the next.)
This allows the select tag to use data from another datasource in its select. For example, if you are pulling customer information from one data source, you can then pull data from the sales datasource using the customer ID of the customer presently processing to pull the sales information for that customer. If you're interested in patching together your data from multiple datasources, read this post on our blog.
