An analysis of GlobalData trial data extracted in September 2026 shows that company-sponsored Phase I–III trial volume increased by approximately 10% between 2021 and 2025. Over the same period, radiopharmaceutical therapy trials grew by 106%, cell and gene therapy (CGT) trials by 29%, and antibody-drug conjugate (ADC) trials by 202%. The three modalities also have different development profiles. Radiopharmaceutical trials are concentrated in Phases I and II, CGT trials are predominantly in Phase II, and ADCs have the highest proportion of Phase III trials among the three.¹
Because these studies are so operationally complex, clinical supply planning is a critical part of clinical operations, particularly during the early stage of project planning. Clinical supply is interconnected with protocol design, site readiness and delivery to the patient. Regulatory approval, site activation and product availability all need to be coordinated around the planned treatment date.
Why new modalities are different
Each modality brings its own operational challenges. Radiopharmaceuticals can have short usable lifetimes, depending on the product and radionuclide, so delivery timing must be precise, and they require radiation handling and sites with the appropriate facilities and authorizations of licenses. Autologous cell therapies are manufactured from a patient’s own cells and require strict chain of identity and chain of custody, patient-specific manufacturing slots scheduled around each patient and, where required, cryogenic logistics. Other cell and gene therapies have different manufacturing, storage and delivery requirements. ADCs contain cytotoxic payloads, making hazardous handling, stability management and pharmacy readiness at the site are critical. Across all three, success comes down to handling, timing and traceability.
The central question for every one of these trials is this: can we get the right therapy to the right patient, at the right time, under the right conditions, and deliver it safely? Each of these five conditions is a shared concern for clinical operations, clinical supply, manufacturing and site teams, with clear responsibilities for each. If any one of them fails, dosing may be delayed or prevented.
Connecting clinical operations and supply planning
That is why clinical supply must be planned alongside trial operations in complex new-modality trials. Planning these activities together allows teams to assess supply requirements before committing to countries, sites and treatment schedules. For the new modality programs, we need an integrated, approach in which planning, site readiness, manufacturing, logistics and dosing are all connected around the patient.
The first principle is to engage clinical supply early. Supply planning should begin when the protocol is being designed, not after the sites are selected. At protocol design, visit schedules and dosing windows need to be checked against shelf life, manufacturing lead time and preparation requirements. At country and site feasibility, alongside patient access and investigator capability, teams need to assess import requirements/regulations for each participating country, site storage, pharmacy capability, and radiation or cell-handling readiness. Site selection needs to account for both recruitment potential and the ability to meet the product’s handling and dosing requirements.
At start-up, site activation and staff training should go hand in hand with depot strategy, labeling, release and contingency arrangements suited to the product. During enrollment and treatment, recruitment pace informs forecasting resupply. Teams also need agreed procedures for assessing temperature excursions and responding to delays. Decisions about where, when and how patients are treated have direct supply consequences.
The second principle is to move beyond planning to shared, timely visibility. Planning alone is not enough, because trials never go exactly to plan. Enrollment speeds up or slows down, a site is delayed, or a shipment is held at customs. Clinical operations and the clinical supply chain therefore need to share an up-to-date view of patient scheduling, enrollment, site readiness, inventory and shipments. When both teams see the same data, they can identify risks earlier and coordinate a response. They also need to agree who acts when a change in one part of the study affects another—for example, when a dosing date moves after manufacturing or shipment has been scheduled.
Lessons from Radiopharmaceutical, Cell therapy and ADC trials
Experience across these modalities illustrates why clinical operations and product readiness need to be planned together.
In a first-in-human radiopharmaceutical oncology program across multiple academic centers in the United States, site activation depended on far more than ethics approval and contracts. Because the product was manufactured on site, each radiopharmacy had to be validated before the site could open. Rather than treating this as a separate workstream, the team built a single activation plan covering every dependency. Clinical start-up milestones were linked directly to radiopharmacy readiness. Site contracts, ethics submissions and site preparation ran in parallel. Investigators were engaged early, and infrastructure and imaging readiness were tracked alongside activation. As a result, these complex first-in-human sites were activated within competitive oncology start-up timelines. The lesson was clear: a site is not truly ready until both its clinical and its product infrastructure are ready.
In a cell therapy trial, the study began in Australia and then expanded into South Korea and Taiwan. The challenge was to enter new countries without disrupting ongoing enrollment, while making sure the investigational product arrived in step with site activation and the first patient's treatment. A solid understanding of each country’s regulatory requirements was essential, so that supply could be ready to ship as soon as regulatory approval allowed the product to be imported the required regulatory and import permissions were in place. Site activation, regulatory approvals and product arrival were therefore all planned against patient milestones, with cross-regional project management and regulatory teams coordinating readiness from end to end. The program secured approvals in the new countries efficiently while the core study kept its momentum, showing that country expansion works best when activation, product arrival and patient timing are planned together. The lesson for country expansion is to plan approval, activation and product availability against the intended treatment date, rather than treating regulatory approval as the final measure of readiness.
In an ADC oncology program, the sponsor needed to move quickly into countries with strong recruitment potential and fast approval pathways. The risk was that product import, depot setup and distribution would not keep pace with an accelerated start-up. Instead of running these activities in sequence, clinical and supply readiness were managed in parallel. Import licensing, product labeling and site contracts advanced together, and labeling and import requirements were prepared before the sites were activated labeling and import requirements were addressed before site activation. Experienced sites were prioritized, and project management, regulatory and vendor teams worked closely together to identify and address risks early. The program moved from award to regulatory submission in a matter of weeks, demonstrating the value of running clinical start-up and product readiness as one plan rather than one after the other. Above all, experience made the difference, both at the sites and in the CRO team an important start-up milestone. To translate that speed into patient treatment, import, depot and distribution readiness also needed to keep pace.
Five decisions to agree before enrollment
Taken together, these experiences point to five decisions for clinical operations and supply partners to make with sponsors and sites.
- Planning: Can the proposed visit schedules and dosing windows be supported by manufacturing, release and delivery timelines?
- Site selection: What product-handling capabilities must be confirmed before a site is selected and activated?
- Forecasting: How will changes in enrollment or patient scheduling affect manufacturing slots, inventory and resupply?
- Monitoring: What information will teams share, how often, and which changes require action?
- Responding: Who will decide what happens when product availability and a patient’s planned treatment no longer align?
New modalities bring new science, but they also require new decisions. Regulatory approval, site activation and readiness to dose are distinct milestones. Planning must connect all three, so that when a patient is ready for treatment, the product, site and clinical team are ready too.
This article is adapted from my presentation at BioPlus 2026, Seoul, South Korea.
¹ Source: GlobalData, data extracted September 2026. Analysis of company-sponsored Phase I–III trials by start year, including planned, ongoing and completed trials. Phase II includes Phase I/II; Phase III includes Phase II/III. Growth comparisons cover 2021–2025.