The clinical trial landscape has seen unprecedented advances in automated data collection. Cutting-edge technology enables the interrogation and aggregation of vast quantities of data, which brings with it significant challenges in analysis and interpretation.
Drug discovery and development is a long, costly, and a high-risk process. Trials need to be done quickly and efficiently to preserve as much time as possible from the drug’s patent life to gain a return on investment. The average for each new drug to be approved for clinical use is on average USD$1-2 billion. Moreover, according to the Center for Study Drug Development, over 80% of clinical trials fail as they cannot meet regulatory requirements, resulting in delayed drug commercialization and decreased peak sale volumes.
The pressure to complete research as quickly as possible has increased complexity of studies and so intensified the challenges in executing trials, raising the stakes on data quality and its return on investment. Data capture must be visible from the get-go for accurate and effective data analysis and interpretation. Accordingly, modern data capture tools must live up to unprecedented expectations, with clinical teams under significant pressure to choose the right ones.
According to Grand View Research, the global electronic data capture (EDC) systems market size is expected to be valued at USD 1.16 billion by 2025.
Why don’t small to mid-size pharma have a firm grip on their data capture?
Despite the increasing demand and supply for EDC, small and mid-sized pharma companies still struggle with cost effective and resource-efficient data capture. They experience more challenges than their larger counterparts for many reasons. For example, a reliance on using a contract research organization (CRO) to support smaller and less experienced data management and clinical teams.
A more efficient use of budget might be to choose a technology that can do more of the heavy lifting, thereby lowering support and data cleaning costs allowing for more throughput – trials, time to market, offsetting costs and recouping initial investment.
Mainstream EDC systems have been eagerly adopted by large pharma companies, who can run large clinical trials, across multiple countries, often with complex protocol designs to get the best return for the trial time and cost. Consequently, many EDC systems’ have evolved configurations and user interfaces which can be (and often unnecessarily) complicated for an end user —adding additional risk to an already complex trial process.
Sometimes, in the bid to attract smaller pharma companies, EDC vendors may offer systems as a ‘cheaper’ price point, sometimes by limiting available functionality or inter-adaptability which may not provide the level of efficiencies and risk management that smaller companies need. Small and mid-size companies are then inadvertently restricted to EDC platforms of limited capability and sophistication, leading to more cost, frustration and delays.
More, EDC vendors tend to prioritize providing support to their big pharma customers. This is understandable taking into account relative revenue streams. Unfortunately, this leaves the smaller and mid-sized pharma companies struggling with a limited platform together with second best implementation and support. As the main EDC systems are built on aging hardware and software concepts even the big pharma companies have to deal with slow performance, downtime, and slow bug fix provision, on top of what are relatively expensive products to being with.
These issues have significant negative consequences: primarily slowing trials and leading to higher management and monitoring costs, inefficient team processes, disengaged patients, and frustrated sites, and inevitably reduced revenue.
Increasing advances in data capture technologies are driving more focused studies
Electronic data capture holds many advantages over manual, paper-based processes. Primary among these is its ability to facilitate the efficient capture of high-quality data without the delays associated with shipping paper case report forms (CRF) between site and Sponsor.
Successful data capture is cost, time, and resource-efficient for the site, and whilst meeting data security and compliance requirements. It should be granular and be able to report all the clinical data points as well as meta data surrounding that clinical data. Finally, it should give clinical teams and decision-makers quick and easy access to the captured data for visualization, patient safety overview and quicker decision making.
Many EDC systems say they can meet most of these criteria for big pharma. But do they deliver for all sizes of pharma companies?
Encapsia is the most intuitive EDC tool available on the market. Its advanced navigation gives complete flexibility and adaptable configuration and powerful user experience for complex trials.
Clinical teams and decision-makers can quickly access, search and get real-time visibility into clean data whenever needed. Encapsia offers multiple, flexible data entry options, and its modern user interface makes its use easy for team members with all levels of technology expertise. Find out more about encapsia’s EDC Entry here.
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