Therapeutic context shapes every operational decision in Phase I–II. Our teams bring indication-specific experience to each programme, so the operational plan reflects the science of the disease area, not a generic template.
Each therapeutic area introduces its own constraints in design, recruitment, endpoints and regulatory oversight. Our operational plans reflect the science of the disease area at every stage of Phase I–II.
From first-in-human through combination immuno-oncology and proof-of-concept designs, we run early-phase oncology end to end, for targeted therapies, checkpoint inhibitors, antibody-drug conjugates and novel small molecules. Safety governance, cohort decisions and biomarker workflows, kept moving on schedule.
We bring senior haematology operations experience to programmes with narrow, high-acuity patient populations, coordinating feasibility across specialist centres, qualifying Phase I units, and holding a rigorous safety-monitoring cadence through dose escalation.
In rare disease, feasibility is everything. We build cross-border recruitment strategies, identify the right expert centres, and develop the investigator relationships that make low-volume studies work, with the EU Orphan Regulation and FDA orphan-drug pathways built in from the feasibility stage.
In early-phase CNS, where proof-of-pharmacology is often the objective, endpoint integrity matters as much as safety. We handle complex protocol management, rater qualification and standardisation, digital biomarker and wearable integration, and long-cycle follow-up and retention.
Our cardiovascular experience spans cardiac safety pharmacology (TQT, QTc), early heart failure and coronary artery disease, and cardiometabolic development. We coordinate ECG core labs, cardiac imaging, biomarker workflows and the intensive safety monitoring these programmes require.
ATMPs, CAR-T, viral-vector gene therapies, ex-vivo gene-edited cells, run on a different operational backbone: chain-of-identity and custody, cryogenic logistics, specialist site qualification, and intensive post-infusion monitoring. We coordinate apheresis logistics, batch-release documentation and ATMP site qualification, aligned to EMA CAT and FDA CBER guidance.
Infectious disease programmes move fast. We bring protocol-adaptive operational frameworks, accelerated site activation, adaptive dosing and compressed monitoring cycles, calibrated to the urgency of the indication. We support early-phase vaccine studies, healthy-volunteer safety and immunogenicity designs, with the cohort management, safety oversight and sampling logistics these programmes depend on.
We support Phase I–II programmes across autoimmune and inflammatory indications, bringing the operational discipline these long-cycle, biomarker-driven studies require, from patient stratification and endpoint standardisation to the safety monitoring cadence that immunomodulatory compounds demand.
Inventio Science also supports Phase I–II programmes across metabolic disorders, immunology and transplantation, dermatology, and novel-modality platforms, oligonucleotide therapies, RNA-based medicines and bispecific antibodies.
Tell us which indication you are working in and where you are in development. A senior member of our team will respond within two business days.
