These are exciting times in biologics.
Since 1995, applications for biotech patents have increased 25% year-on-year and biologics currently make up more than 50% of drugs in development. And, with many big deals already on the ledger this year, 2018 is on track to be a popular one in terms of M&A activity in the industry.
Yet, biologics brings challenges too. While they generally enjoy better approval rates than traditional drugs, they take much longer to approve due to strict manufacturing methods and regulatory pathways along with many more in-process tests during development.
This complex process produces much more data which begs the question on every research scientists’ lips: “How should findings be gathered to produce high quality, reliable and statistically sound data?”
No matter how well a trial is put together, if the data gathering tools are badly applied, the results will be below par, seriously impacting the trial and failing to answer the clinical trial’s questions.
This means that data needs to be recorded and stored with precision, intuitive to use and well designed. Much is invested in clinical trials and if the findings aren’t gathered accurately, the whole project is thrown into jeopardy. As a result, modern technology plays a critical role in the data gathering process, making sure the quality of data is high.
As the global biologics outsourcing market continues to grow – it’s expected to reach $32 billion by 2024 – so will electronic data capture software, to keep up with the changing trends, standards and stricter regulatory requirements while improving study efficiency.