IAG Monthly | August 2026: Early-Phase & Late-Phase Clinical Trials

August was a month of growth and evidence generation in imaging-led drug development, with early-phase decision-making, AI-enabled endpoints, and regulatory readiness all firmly in focus.

From the opening of our new Boston-area office and an August webinar attended by more than 130 biotech and pharma executives, to IAG’s 19th anniversary, one message was consistent: the imaging strategy established in Phase I is fundamental to building a credible, defensible Phase III program.

Sponsors increasingly face two critical questions at pivotal points in development:

In Phase I and early Phase II: Does the drug reach its target, and is the early signal strong enough to justify expansion?

In Phase III: Will the imaging evidence withstand blinded independent central review, endpoint adjudication, and regulatory scrutiny?

Our team at IAG helps make both questions answerable through one harmonized imaging backbone – linking early biological insight to late-stage, submission-ready evidence.

This month, we brought that capability closer to the biotech ecosystem that needs it most.

We are pleased to announce, Image Analysis Group (IAG) has opened a new U.S. office in Kendall Square, Cambridge, Massachusetts, placing the team at the center of one of the world’s most concentrated life-sciences ecosystems in the world.

The office hosts operations and business development  teams, and provides a local base to support sponsors, CROs and biotech’s advancing innovative Phase I–III trials across oncology, neuro-oncology, radiopharmaceuticals, immunology, rheumatic and musculoskeletal, metabolic and cardiometabolic, and rare disease.

IAG plans 20-25 hires across clinical imaging operations, data science, regulatory support and business development over the next 12–24 months (EIN Presswire release).

“This expansion marks an important milestone in IAG’s growth strategy. Boston is a global epicenter for biotech innovation, and establishing a presence here allows us to work more closely with our clients as they advance complex, imaging-driven clinical trials. By being on the ground, we can collaborate more effectively, respond faster, and deliver the high-quality imaging insights that are critical to accelerating drug development.” — Dr. Olga Kubassova, CEO, Image Analysis Group (IAG).

“Cambridge and the greater Boston area represent one of the world’s most concentrated and dynamic life-sciences ecosystems. Our new office sits at the heart of what is often described as the densest square mile of biotech research and innovation anywhere… Having a dedicated local presence enables us to build deeper, more responsive relationships with the sponsors and CROs advancing next-generation therapies.

As someone who has spent his career at the intersection of UK and U.S. life sciences, I see this office as a natural extension of that bridge, giving our team the local footprint to support sponsors’ imaging needs from early trial design and protocol development through to regulatory submission.” — Mike Fisher PhD FRSC, VP Business Development & Strategic Partnerships, Image Analysis Group (IAG).

Read the full PR article: Image Analysis Group (IAG) Expands U.S. Presence with New Boston-Area Office Opening

If you are Boston-based – sponsors, CROs and investors are welcome to book a face-to-face imaging strategy session with the local team: contact@www.ia-grp.com

Early-phase trials are increasingly data-rich, and imaging has moved upstream from a response-assessment tool to a decision-making instrument. Late-phase trials, meanwhile, carry the heaviest imaging burden of the entire lifecycle. The two are not separate problems, they are the same problem, separated by three to five years.

Where imaging earns its place in Phase I / early Phase II:

• Safety and tolerability — detecting organ-level or structural change before it becomes a clinical event.
• Target engagement and proof of mechanism — molecular PET and functional MRI showing the drug reaches and acts on the intended target.
• Early efficacy signal — quantitative, reader-independent change that supports objective go / no-go calls.
• Patient selection and cohort enrichment — imaging-based stratification that reduces the number of patients needed to see an effect.

Independent market analysis supports the shift: Phase I imaging is forecast to grow at a 10.12% CAGR through 2031, driven by imaging biomarkers moving upstream to support dose selection, patient stratification and early pharmacodynamic measurement with whole-organ perfusion MRI, dynamic contrast-enhanced CT and molecular PET enabling non-invasive quantification and reducing reliance on invasive biopsies (Mordor Intelligence).

Why late-phase discipline starts early:

Phase III programs consumed 40.95% of clinical trial imaging market outlays in 2025, because pivotal studies demand global site harmonization, blinded independent central review, rigorous archiving, multiple modalities, repeat scanning, data locks synchronized to interim analyses, endpoint adjudication committees and duplicate reads (Mordor Intelligence). With the median cost of a single Phase III trial exceeding USD 19 million (Grand View Research), imaging variability introduced in Phase I is an expensive thing to discover in Phase III.

What IAG delivers across both ends:

Through DYNAMIKA™ and our central review model, IAG enables:

• Protocol and modality selection driven by the development question, not habit (MRI, CT, PET or multimodal).
• Site qualification, acquisition standardization and image QC that cut re-scans, variability and data-cleaning effort.
• Centralized, blinded independent central review built to withstand regulatory scrutiny in pivotal studies.
• AI-assisted and radiomics analysis supporting stratification, cohort enrichment and credible early-efficacy claims.
• Near real-time sponsor dashboards giving clinical and executive teams visibility of image quality and endpoints as data arrive.
• Regulator-ready audit trails and reporting from first-in-human through to submission.

This is how imaging becomes a decision-driving asset towards regulatory approval rather than a downstream cost line towards trial failure.

Over 130 registrants joined us — thank you to everyone who took part.

The session introduced the role of an iCRO and of DYNAMIKA™ in executing the imaging components of early-phase trials: from protocol decisions and site strategy, through central review, to the use of quantitative endpoints in regulatory discussions.

Therapeutic areas of focus: Oncology, Autoimmune Diseases, Musculoskeletal, Obesity and Metabolic Diseases, and Rare Diseases where imaging can inform safety, drug response, early efficacy, patient selection and proof-of-mechanism decisions.

🔸 How imaging and AI-enabled endpoints change early decision-making — where imaging adds the most value in Phase I and early Phase II (safety, target engagement, drug response, early efficacy), and how those readouts support objective go/no-go and portfolio decisions.

🔸 Designing imaging strategies around business questions, not just modalities — when to use MRI, CT, PET or multimodal approaches to answer specific development questions: “Does the drug reach the target?”, “Are we seeing the expected mechanism?”, “Is there enough early efficacy to justify expansion or further investment?”

🔸 Building endpoints that support trial enrichment and investor confidence — how smart imaging endpoints, radiomics and AI-assisted analysis improve patient stratification, cohort enrichment, and the credibility of early efficacy claims to internal governance and external stakeholders (boards, investors, partners).

🔸 Operational playbook: reducing start-up delays and quality risk — practical steps for protocol design, site selection, acquisition standardization, image QC and central reads that cut down re-scans, variability and data-cleaning effort, enabling faster, cleaner datasets for daily and interim reviews.

🔸 Using DYNAMIKA™ and centralized imaging to get faster, cleaner data — how centralized reads, cloud-based data management and AI-enabled analysis deliver near real-time visibility of image quality and endpoints, so sponsors can move from data capture to meaningful decisions more quickly across multi-location teams.

🔸 Real examples from early-phase programs — case sketches showing how sponsors have used imaging and AI to rescue or re-position a program based on early signals, make confident decisions to stop or accelerate development, and design smarter expansion cohorts and Phase II strategies.

Whether you are a CEO, CMO or Clinical Operations leader, the session provided a practical framework for planning imaging-heavy studies over the next 6–12 months, aligning operational strategy with business milestones, and using imaging and AI to de-risk early clinical development.

Watch the recording: Current Role of AI and Imaging in Early Phase Clinical Trials | IAG

Imaging-led development continues to accelerate at both ends of the pipeline:

• The clinical trials market is projected to grow from USD 94.0 billion in 2026 to USD 158.4 billion by 2033 (7.7% CAGR), with North America holding 50.7% of revenue and Asia-Pacific the fastest-growing region (Grand View Research).
• Early-phase clinical trial outsourcing is expanding from USD 10.39 billion in 2026 to USD 14.8 billion by 2030 (9.2% CAGR), driven by biotech startup expansion, precision medicine, rare disease research, adaptive and first-in-human designs, and AI in trial analytics (ResearchAndMarkets via GlobeNewswire).
• The clinical trial imaging market reaches USD 1.42 billion in 2026 and USD 2.04 billion by 2031 (7.47% CAGR), with oncology contributing 32.05% of 2025 revenue, rare disease the fastest-growing therapeutic segment at 9.93% CAGR, and PET the fastest-growing modality at 9.29% CAGR (Mordor Intelligence).
• AI has crossed from pilot to practice in imaging: more than half of healthcare organizations now deploy AI in at least one imaging workflow, up from 17% in 2018, and the FDA lists more than 300 cleared AI imaging devices (Mordor Intelligence).
• Outsourcing imaging to a specialist iCRO can trim study timelines by up to 30% through centralized image data and predefined read algorithms, with CRO-delivered imaging forecast to grow at a 10.78% CAGR through 2031 (Mordor Intelligence).
• The regulatory and standards environment is tightening in imaging’s favor: full use of the EU Clinical Trials Information System was mandated from January 2025, ISO 12052:2026 (DICOM exchange and information management) published in February 2026, and ISO 14155:2026 (GCP for device investigations) in March 2026 (Mordor Intelligence).
• Phase III outsourcing has room to run — only about 35% of Phase III trials are currently outsourced, a share expected to rise as more investigational drugs advance (Grand View Research).

For investors and executive teams: programs that establish centralized, harmonized imaging in Phase I carry that asset forward into pivotal studies. Those that defer it pay twice — once in early ambiguity, and again in late-phase remediation. Imaging maturity is now a legitimate due-diligence question.

DYNAMIKA™ supports these dynamics daily by providing a scalable, regulator-ready imaging and analytics backbone from first-in-human through to registration-directed development.

This month we marked 19 years of Image Analysis Group (IAG).

From research roots to global reach, focused on bringing meaningful technology into drug development. Now pushing how AI, data and imaging can truly impact clinical trials as the healthcare industry continues to evolve.

The real strength is always with the people. The ones who imagined, built, scaled it, and kept raising the bar as we continue to expand globally. We feel grateful for bold ideas, relentless drive, and the warmest support of everyone who has supported the IAG journey.

19 years in – grounded in what we have built, focused on what is next. Happy birthday everyone!

Read the post: 19 Years of Science, Innovation and People | IMAGE ANALYSIS GROUP

IAG’s Official Congress Calendar (Q4 2026):

• H.C. Wainwright 28th Annual Global Investment Conference – New York, USA (14–15 September 2026)
• Oppenheimer Radiopharma Day – New York, USA (17 September 2026)
• Biotech Week Boston – Boston, MA, USA (22–25 September 2026)
• EANO Congress – Rome, Italy (24–27 September 2026)
• Biotech on Tap – H.C. Wainwright – Munich, Germany (30 September – 2 October 2026)
• ICRS Summit (Cartilage) – Porto, Portugal (8–10 October 2026)
• ASBMR Annual Meeting – Boston, MA, USA (9–12 October 2026)
• EANM Congress – Vienna, Austria (17–21 October 2026)
• ESMO Congress – Madrid, Spain (23–27 October 2026)
• SITC Annual Meeting – Phoenix, Arizona, USA (4–8 November 2026)
• AASLD The Liver Meeting – Denver, Colorado, USA (5–9 November 2026)
• ACR Convergence – Orlando, Florida, USA (8–11 November 2026)
• SNO Annual Meeting – Philadelphia, USA (12–15 November 2026)
• ObesityWeek – Washington DC, USA (14–17 November 2026)
• Jefferies / London Life Sciences Week – London, UK (15–19 November 2026)

Planning to attend any of these? Let us know in advance and we will set up time to connect on the day: contact@www.ia-grp.com

Subscribe to IAG’s YouTube channel: Image Analysis Group (IAG)

Recently Published Webinar Recording: A Practical Guide to Imaging in Radiopharmaceutical Trials | Rapid LLC & Cellectar Biosciences, Inc.

As clinical trials grow more complex — across oncology, radiopharmaceuticals, metabolic disease, musculoskeletal, autoimmune and rare disease — imaging has moved from a supporting measure to a core determinant of whether a study succeeds.

August made that concrete for us in three ways: a new Boston-area base putting our team alongside the sponsors making these decisions, a webinar showing 130+ attendees exactly how early-phase imaging strategy translates into portfolio decisions, and 19 years of accumulated evidence that getting imaging right early is what makes late-phase readouts defensible.

At IAG, we bring together scientific expertise, AI-enabled technology and global operational delivery so that every image contributes clear, decision-ready insight throughout the life of a trial. Whether we are supporting a first-in-human study or a registration-directed Phase III, our aim is always the same: reduce uncertainty, keep studies on track, and give your teams the evidence they need to deliver successful clinical outcomes.

www.ia-grp.com

Follow IAG on LinkedIn: IMAGE ANALYSIS GROUP | LinkedIn

Now also in Cambridge, Massachusetts — alongside London, EU and India

Book a strategy discussion: contact@www.ia-grp.com

• EIN Presswire — Image Analysis Group (IAG) Expands U.S. Presence with New Boston-Area Office Opening: https://fox59.com/business/press-releases/ein-presswire/937225987/image-analysis-group-iag-expands-u-s-presence-with-new-boston-area-office-opening/
• Akron Beacon Journal / EIN Presswire (full release text): https://www.beaconjournal.com/press-release/story/227058/image-analysis-group-iag-expands-u-s-presence-with-new-boston-area-office-opening/
• Mordor Intelligence — Clinical Trial Imaging Market Size & Share Analysis (2026–2031): https://www.mordorintelligence.com/industry-reports/clinical-trial-imaging-market
• Grand View Research — Clinical Trials Market Size, Share, Growth Report 2026–2033: https://www.grandviewresearch.com/industry-analysis/global-clinical-trials-market
• ResearchAndMarkets via GlobeNewswire — Early Phase Clinical Trial Outsourcing Research Report 2026: https://www.globenewswire.com/news-release/2026/04/24/3280610/0/en/early-phase-clinical-trial-outsourcing-research-report-2026-14-8-bn-market-opportunities-trends-competitive-landscape-strategies-and-forecasts-2020-2025-2025-2030f-2035f.html
• Precedence Research — Clinical Trial Imaging Market: https://www.precedenceresearch.com/clinical-trial-imaging-market
• Towards Healthcare — U.S. Clinical Trial Imaging Market: https://www.towardshealthcare.com/insights/us-clinical-trial-imaging-market-sizing
• GM Insights — Clinical Trials Market Size & Share 2026–2035: https://www.gminsights.com/industry-analysis/clinical-trials-market
• FDA — Clinical Trial Imaging Endpoint Process Standards, Guidance for Industry: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-imaging-endpoint-process-standards-guidance-industry
• IASLC — 2026 World Conference on Lung Cancer, Seoul: https://wclc.iaslc.org/welcome-message/
• EASD — 62nd Annual Meeting 2026, Milan: https://www.easd.org/annual-meeting/easd-2026/
• ESMO — 2026 Congress, Madrid: https://2026esmo.org/
• American College of Rheumatology — ACR Convergence 2026, Orlando: https://rheumatology.org/annual-meeting