How is a new pharmaceutical product developed? It goes through a slow and expensive clinical trial process to check for effectiveness and safety. Those R&D organizations who used to stick to the traditional non-digital approach, have spent a lot of time and money while relying on paper diaries and obsolete software to get the results. To take action, the industry begins to adopt digital transformation and modernize the clinical trials value chain with data-driven software solutions and innovative technologies.
Many life science companies have already started bringing single solutions to the clinical trial process, like connected health devices or electronic signatures. But few are ready to digitalize clinical trials all the way through.
According to Accenture research, by 2020, the pharma market will experience one-third of digitalization growth and approximately 40 percent of the profitability.
That’s why in our new article, we put our focus on the digital transformation of clinical trials process and software solutions that power up each stage of it.
Stage 1. Pre-study
Pre-study, or trial design stage is a complex process that covers everything from defining inclusion and exclusion criteria to setting recruiting targets, data collection, building strategies and checking feasibility. The main goal here is to understand what is the most critical for the specific trial by gaining insights from real patients through connected health devices, health records and patient interactions.
That’s where digital technologies come into play: clinical trials organizations can leverage cloud technologies real-world evidence (RWE) and real-world data (RWD) for the collection, storage, and analysis of information. Surprisingly, even this may be not enough. To analyze the needs of a broader patient community, R&D companies should consider patient feedback given on social media, interactive patient websites, mobile apps, and discussion forums.
Stage 2. Study Start-Up
Start-up stage embraces site recruitment, retention and monitoring. These activities are normally associated with a lot of paperwork caused by legal requirements to the documentary: investigator agreements, financial disclosure dorms, approval letters, etc. What is more, all the papers are generally good for a year, while a trial may last much longer. Digitalization with the help of centralized document management software helps reduce the administrative burden by treating document flow as a continuous process with automatic renewal of expired documents.
Which clintech solutions may empower study start-up process?
- Robotic automation of digital calendar with email generation to notify about upcoming documentation updates or renewals help guide the entire process.
- Natural language processing help analyze investigators CVs, licenses, and financial disclosures to understand whether they are already on file and are updated.
- Artificial intelligence tools could leverage predictive analytics to improve site selection, enhance value, and reduce costs.
All-in-all, digitalization must leverage paperless collaboration, consistency in document formats, 24/7 access to all the records within a secure cloud-based storage.