ECRF stands for Electronic Case Report Form, and it refers to the paper or questionnaire that is used in clinical research. Clinical research is necessary to get new drugs tested and approved and out into the market for human use. With the case of the new coronavirus, scientists and medical researchers are desperately trying to develop a new vaccine that can be rolled out to combat the spread of the virus. The process of developing a new drug or vaccine can range from anywhere between 10 years and sometimes up to 20 years. It also costs vast sums of money, which is ultimately felt by the consumers at the end of the line. Smart ECRF design can drastically help speed up this process and cut the time down and save a lot of money. At this stage with the current corona virus issue, anything that can be done to reduce the time it takes to develop the new vaccine is being explored, since time is very much of the essence.
What Is ECRF Design?
ECRF is the paper or form that goes alongside clinical trial research. Every single participant in the trail stage must have their data collected in one of these forms. Previously they were known as just CRF, before the collection and management of this data was all completely electronic. The thing about these forms is that since it is a standardised format, it must be used when submitting drugs and medicines to the regulators, such as the FDA. This means that there is no escaping the fact that you need these forms to be accurate and approved by regulators in order to get drugs approved. Companies can spend many months trying to develop their own ECRFs, but by using a company that specialises in optimal ECRF design, they can cut this time frame down to just 4 weeks.
Data Is Important
Data is absolutely vital to the process of making clinical studies run. Participants are usually monitored on a whole host of data points and that is before their own personal information is even considered. During their participation, their personal data such as name, date of birth, record number, medical background, fitness levels and more are captured and collected, but before being sent to the regulator, this data must be de-identified. i.e. their data must be stuck off and kept anonymous prior to submission. This can very often be done by a overseeing body or regulator.
Cutting Down On Errors
From the point of view of both the drug companies and the regulators, the data that is being submitted should ideally be accurate and properly compiled, but this is rarely the case when it comes to hundreds of different points of data. When using a smart ECRF design company, this will very often include an auditing service which means that the data is kept a close eye on and will ultimately be of a higher quality. These companies make sure that the data is all automated for accuracy and it will stand the best chance of being accepted.