Looking at 2018, there are several shifts in clinical trial outsourcing trends that sponsors and vendors should be aware of. Many of these trends are driven by regulations and industry guidelines as well as a growing need for new therapies.
In 2017 there was a slight increase in clinical outsourcing penetration as it grew from 43 percent to 45 percent (Clinical Leader). While the majority of outsourcing still lies with large, full service CROs, the percentage of work going to specialist CROs is growing due to a need for experts in therapeutic areas and indications, regulatory requirements and pharmacovigilance.
Below is a look at trends in outsourcing that shaped 2018:
Sure, technology has been an ongoing trend in clinical trials for years. Technologies such as Electronic Data Capture (EDC), Patient Recorded Outcomes (PRO) and Clinical Trial Management Systems (CTMS) have become the norm, however technology is now playing a fundamental role in the overall clinical study strategy. Tech giants such as Google, Amazon, and Apple are also looking for a chunk of the clinical trial sector by developing technologies that are patient centricity. Market leaders such as Medidata, Oracle and Veeva are continuing to develop extensive technology platforms for clinical trials.
DATA ANALYTICS ARE FUNDAMENTAL
Centralized statistical monitoring is being mentioned more frequently as Sponsors look to facilitate risk-based monitoring with real-time, accurate metrics. Data analytics will play an even greater role in crucial strategic decisions for Sponsors.
PHARMACOVIGILANCE OUTSOURCING (PVO) ON THE RISE
Pharmacovigilance Outsourcing got its own acronym and some attention in 2018. The management and reporting of adverse events is becoming a complex business and new regulations are making it more difficult for Sponsors to keep up without support from specialized experts.
BIOTECH GOING AT IT ALONE?
Biotechs have often looked to large pharma partnerships to carry their compounds into late phase trials and on to approval. Biotechs now have multiple outsourcing models available including Functional Service Provision to allow them to continue developing their product.
RISE OF STRATEGIC PARTNERSHIP MODEL AND FSP
Over 60 percent of Sponsors have started outsourcing in-house activities to “strategic partners”. For clinical, data, regulatory and clinical IT solutions, Sponsors are increasingly looking to the Functional Service Provision model.
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