Automation is the answer to certain challenges within the pharma industry. Some of these challenges include the need for a detailed clinical study report in the process to produce drugs as well as the desire to reduce the hefty spending on processes involved in drug production, among other challenges.
Despite the importance of documenting the processes and results, scientists and researchers also need to have more time to focus on the science of drug production. By automating the necessary yet time-consuming process of document production, the pharmaceutical companies can save time, adhere to guidelines, and save money. Let us take a look at the role automating documents in this industry plays.
Regulatory compliance is a key aspect of the pharma industry. Every industry player needs to provide information about the trials being carried out. This needs constant taking of notes and recording of information that comes from different sources. Right from the beginning, there is a lot of work involved in planning the different types of clinical study reports which include: full report, supplemental, abbreviated, and synoptic.
All these have several chapters or sections and writing up such reports can be more work than carrying out the actual tests. The documents are however important to ensure compliance with FDA regulations. Automating the process of compiling the reports will free up time for the scientists and make it possible to generate the documents without spending time and resources on it.
The pharmacy industry depends on research carried out by other scientists to support current studies. Even when justifying carrying out particular trials, it is necessary to quote supporting documents. By automating, it becomes easier to find and quote earlier research. Extracting data from journals and papers is simplified since with a few clicks of the keyboard, all the information about past trials can be discovered.
This means scientists will not miss important information about particular trials since it will be available in digital form. Research is made more thorough when pharma documents are automated.
During clinical trials, there are several locations where trials may be carried out and they need to send reports of any adverse effects. It can be overwhelming if the scientists receive and enter data from different locations manually. Imagine entering data from over 200 countries around the world. There would be a risk of error in data entered not to mention some data being missed.
With document automation, the software will handle all the information coming in from several locations and enter it according to set guidelines. This information is updated whenever new data comes in so the final report will have up to date data. The presentation of this data is also designed for easy analysis. Generating a report and sending it to the regulatory authority or anybody that needs to have the information is swift.
If a pattern of serious side effects is reported, the pharmacy company can immediately notice the trend and take quick action to prevent more damage.
There is a race to get life-saving medications onto the market but this cannot be done without fulfilling certain procedures. A lot of these procedures involve documenting the trials. This process can take up a lot of time especially if it has to be done manually. With document automation software, the process is expedited right from the capturing of data to the forwarding of reports to the FDA.
Report generation can be scheduled and programmed so that as information comes in, it is entered into the document and on a scheduled date, the report can be forwarded to the concerned authorities for approval. Observations and analyses are easily incorporated into a report almost instantly.
With automated documents, it is possible for pharma companies to collaborate across continents and not have to worry about challenges that would be faced if they had to use manual documentation. The software makes it possible for every team to have access to the different reports and they can even be translated into different languages. This makes it easy for a Chinese scientist to share clinical trial documents with a scientist in Germany.
Automation is an important part of creating a more efficient process in the pharmacy industry. The cost of clinical trials and the production of drugs can be scaled down and time slashed. Decisions can be made in real-time and communication can transcend language barriers.