ISPOR CEO Rob Abbott on why HEOR must be in the room when clinical trial tech is built, and what ISPOR’s latest Top 10 HEOR Trends Report means for ClinOps.

Spotted on some driftwood on the beach, gamely holding on despite the howling gale. "Different from Clinops", and Albert Edmund Brookes (1879–1968), a prominent New Zealand entomologist and beetle...

What clinops professionals needs to know The surge in IRT system inspections marks a major shift in regulatory expectations for clinical operations. Agencies worldwide are emphasizing audit trail transparency, user access control, and system validation as key measures of data integrity and patient safety. For clinical operations teams, inspection readiness now requires cross-functional training, proactive documentation management, and collaboration with sponsors to ensure full visibility into system development and randomization logic.

What clinops professionals need to know Pharma R&D productivity continues to lag despite record spending, with trial complexity, investigator shortages, and patient recruitment challenges driving high attrition and long timelines. Emerging strategies focus on expanding investigator and patient engagement, leveraging adaptive and decentralized trial models, and aligning early with regulatory and payer expectations. Real-world data and analytics are playing a growing role in indication expansion and portfolio decision-making, offering a pathway to reduce risk and accelerate delivery of therapies to patients.

Key takeaways for clinops professionals Inluriyo reduced risk of progression or death by 38% versus standard endocrine therapy in ESR1-mutated metastatic breast cancer. The oral administration provides a more convenient alternative to injectables, with a manageable safety profile and mostly Grade 1-2 adverse events. The ongoing EMBER-4 trial will determine Inluriyo’s role in the adjuvant setting, with implications for long-term recurrence prevention.

What clinops professionals need to know Strong sponsor–CRO collaboration is critical to keeping global trials on track. Clear communication, realistic timelines, and mutual accountability help manage regulatory differences, site challenges, and patient recruitment pressures. Leveraging project management tools, structured communication plans, and emerging AI solutions can streamline workflows, while flexibility and continuity in teams remain key to delivering studies on time and with quality.

Image Credit: © Pixel-Shot - stock.adobe.com What clinops professionals need to know The Phase II STARLIGHT trial evaluated a single intravitreal injection of MCO-010 in patients with Stargardt disease, demonstrating meaningful gains in best-corrected visual acuity, including early improvements sustained through 48 weeks. The therapy was well tolerated with no serious adverse events. Based on these results, Nanoscope will advance to the Phase III STARGAZE trial, a randomized, double-masked, sham-controlled study enrolling ~60 patients, with top-line results expected in 2027.

PhaseV has launched Enrollment Lab, a new AI-powered solution designed to quantify a clinical study’s enrollment potential and model protocol trade-offs earlier in planning—before protocol lock and pr...

PhaseV has launched Enrollment Lab, a new AI-powered solution designed to quantify a clinical study’s enrollment potential and model protocol trade-offs earlier in planning—before protocol lock and pr...

What clinops professionals needs to know The surge in IRT system inspections marks a major shift in regulatory expectations for clinical operations. Agencies worldwide are emphasizing audit trail transparency, user access control, and system validation as key measures of data integrity and patient safety. For clinical operations teams, inspection readiness now requires cross-functional training, proactive documentation management, and collaboration with sponsors to ensure full visibility into system development and randomization logic.

What clinops professionals need to know Pharma R&D productivity continues to lag despite record spending, with trial complexity, investigator shortages, and patient recruitment challenges driving high attrition and long timelines. Emerging strategies focus on expanding investigator and patient engagement, leveraging adaptive and decentralized trial models, and aligning early with regulatory and payer expectations. Real-world data and analytics are playing a growing role in indication expansion and portfolio decision-making, offering a pathway to reduce risk and accelerate delivery of therapies to patients.

Key takeaways for clinops professionals Inluriyo reduced risk of progression or death by 38% versus standard endocrine therapy in ESR1-mutated metastatic breast cancer. The oral administration provides a more convenient alternative to injectables, with a manageable safety profile and mostly Grade 1-2 adverse events. The ongoing EMBER-4 trial will determine Inluriyo’s role in the adjuvant setting, with implications for long-term recurrence prevention.

What clinops professionals need to know Strong sponsor–CRO collaboration is critical to keeping global trials on track. Clear communication, realistic timelines, and mutual accountability help manage regulatory differences, site challenges, and patient recruitment pressures. Leveraging project management tools, structured communication plans, and emerging AI solutions can streamline workflows, while flexibility and continuity in teams remain key to delivering studies on time and with quality.

Image Credit: © Pixel-Shot - stock.adobe.com What clinops professionals need to know The Phase II STARLIGHT trial evaluated a single intravitreal injection of MCO-010 in patients with Stargardt disease, demonstrating meaningful gains in best-corrected visual acuity, including early improvements sustained through 48 weeks. The therapy was well tolerated with no serious adverse events. Based on these results, Nanoscope will advance to the Phase III STARGAZE trial, a randomized, double-masked, sham-controlled study enrolling ~60 patients, with top-line results expected in 2027.

Clinical ML Pipeline Toolkit — bridging raw clinical data and production-ready ML pipelines

PhaseV unveils the ClinOps platform, leveraging AI for innovative clinical trial operations with precision in site selection and analytics.

RegDev: We’d love to hear about your journey in pharmaceutical consulting. Can you tell us a little about your background and how you got into the field? Jeremy: Over the years I have held various rol...

Powered by Causal AI and Real-Time Patient-Level Data and Analytics, the ClinOps Platform Enables Faster and Smarter Decision Making Across Trial Lifecycles BOSTON, July 1, 2025 /PRNewswire/ -- PhaseV, a leader in AI/ML-driven clinical development, today announced the launch of the...