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.