Former VP at Medidata Solutions Inc
- Overview of e-clinical solutions, CTMS (clinical trial management system) developments and major players – Veeva (NYSE: VEEV), Oracle (NYSE: ORCL) and Medidata
- Demand for clinical trial software post-coronavirus by geography
- Vendor selection criteria by customer size and platform assessment
- Growth runway for EDC (electronic data capture) and eCOA (electronic clinical outcome assessment) subsegments
- 2022 growth outlook and strategic assessments
What major trends and drivers have you been following in the CTMS [clinical trial management system] space since our last Interview [see Clinical Trial Management Systems – Market Update & Competitive Overview – Medidata, Oracle, Iqvia & Veeva – 5 August 2021]?
Could you discuss the regulatory landscape in terms of pharmacovigilance and compliance standards around clinical trials? Are standards becoming less stringent over time, and if so, what are the main implications for CROs [contract research organisations] and software vendors alike, considering US and international regulatory bodies, respectively?
What are your thoughts on CROs’ focus on and adoption of technological solutions vs service offerings? How is the mix from services towards tech trending from an investment and strategic standpoint?
How are you viewing general insourcing vs outsourcing trends for the clinical trial process, considering sponsors, CROs and so on? Are we seeing a greater impetus from sponsors and large CROs to own their own technology and have greater control over the clinical trial journey? How could this dynamic play out over the next 1-2 years?
Could you discuss the respective value propositions of more point-solution clinical trial software vs broader-based offerings such as Iqvia or Veeva’s? Are these targeted more to certain customer sizes, trial focuses or other factors?
How much cross-selling opportunity do larger players such as Iqvia have from their solutions bundles? Is there a substantial advantage to customer retention or revenue maximisation, taking into account the buying criteria you laid out for us?
What’s important to understand about the customer decision criteria for software offerings at different price points? You expounded that cost is more of an ancillary factor when considering software options, but how are customers balancing the value-add for a more premium price point vs a ‘good-enough’ software package that may be more affordable, especially as the macroeconomic environment evolves?
How do pricing dynamics vary geographically? Are we seeing downwards pricing pressure in emerging markets such as India and China? Do cheaper offerings pose a material threat to the incumbents’ positioning, or are there substantial quality or compliance risks to going with a cheaper vendor?
How do you assess the relative CTMS growth runway by customer demographic? Could you juxtapose penetration and market opportunity in larger CROs with more capital vs smaller entities that may have more need to update or innovate their tech capabilities?
How has patient identification and selection for trials evolved? You mentioned a greater emphasis on diversity. How have innovative technologies and software capabilities improved trials’ patient selection capabilities?
How are you viewing the growth potential of CTMS subsegments such as EDC [electronic data capture], eCOA [electronic clinical outcome assessment] and other offerings?
How are CTMS solutions being integrated with EMR [electronic medical record] platforms for better data capture? We saw Oracle announce an acquisition of Cerner in December 2021. Could you discuss the interconnectedness between CTMSs and EMRs and shed some light on how the Cerner acquisition will play into Oracle’s greater life sciences strategy?
What are your thoughts on consolidation trends industry-wide? What can we expect across major CROs buying up tech vendors or even software vendors augmenting their own solutions offerings?
Is there anything that we haven’t discussed that might be especially important to highlight when thinking about the CTMS industry?
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