OPIS
OPIS is recorded as a service provider in 84 clinical trials. Explore its recorded services, study phases and therapeutic areas, with trial-level operational learnings where available.
Clinical trial experience
Showing 20 of 84 trials · Latest update first
KontRASt-03: A Phase Ib/II, multicenter, open-label platform study of JDQ443 with select combinations in patients with advanced solid tumors harboring the KRAS G12C mutation
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who have completed the pediatric ORION-16 , ORION-13, ORION-20, or ORION-19 studies (VICTORION-PEDS-OLE)
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
A phase IV, multicentre, open-label, single-arm study to investigate the efficacy, safety and durability of faricimab (RO6867461) in caucasian patients with polypoidal choroidal vasculopathy
Sponsor Association For Innovation And Biomedical Research On Light And Image
- Start (EU)
- Latest update
- Estimated end
Paclitaxel plus ramucirumab and tislelizumab as switch maintenance versus continuation of chemotherapy and tislelizumab in patients with advanced HER2-negative and PD-L1 positive gastroesophageal adenocarcinoma: the ARMANI-2/ENGIC08 trial by GONO
Sponsor Fondazione GONO G.I.
- Start (EU)
- Latest update
- Estimated end
- Not reported
A multi-center, open-label study to determine the dose and safety of oral asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors.
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation.
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of lutetium (177Lu) vipivotide tetraxetan in Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Moderately and Severely Impaired and with normal Renal Function
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
A phase II, single-arm study of de-escalation and treatment-free remission in patients with chronic myeloid leukemia treated with nilotinib in first-line therapy followed by a second attempt after nilotinib and asciminib combination: DANTE study
Sponsor Novartis Farma S.p.A.
- Start (EU)
- Latest update
- Estimated end
- Not reported
Operational learnings available3 trial-level findings · Read insights
- The study was conducted only in Italy, where all 135 participants were enrolled.
- Slow enrollment and an all-centre feasibility questionnaire identified a relevant gap in reaching the target; the planned sample size was reduced from 136 to 103 and statistical power from 90% to 80%.
- An amendment redefined sustained DMR, loosened a laboratory eligibility criterion, and reduced consolidation-period monitoring-visit frequency.
These findings describe the trial, not the service provider’s performance or responsibility.
A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
An open-label extension study to assess the efficacy and safety of ianalumab with or without study treatment withdrawal in adult participants with lupus nephritis who have completed study treatment in the CVAY736K12301 core study (SIRIUS-LN extension)
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
A phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of the efficacy of citicoline eye drops 2% on visual field preservation in patients with open angle glaucoma
Sponsor Omikron Italia S.r.l.
- Start (EU)
- Latest update
- Estimated end
An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE)
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
A phase 3 multicentre, randomized, prospective, open-label trial of Ibrutinib monotherapy versus fixed-duration Venetoclax plus Obinutuzumab versus fixed-duration Venetoclax plus Ibrutinib in patients with previously untreated chronic lymphocytic leukaemia (CLL) - CLL17
Sponsor University Of Cologne
- Start (EU)
- Latest update
- Estimated end
An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab.
Sponsor Incyte Corp.
- Start (EU)
- Latest update
- Estimated end
- Not reported
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
An open-label, multicenter, roll-over study for patients who have completed a prior Novartis-sponsored sabatolimab (MBG453) study and are judged by the investigator to benefit from continued treatment with sabatolimab
Sponsor Novartis Pharma AG
- Start (EU)
- Latest update
- Estimated end
Activity of Pembrolizumab plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma (REPRINT MeetURO trial)
Sponsor Fondazione IRCCS Istituto Nazionale Dei Tumori
- Start (EU)
- Not reported
- Latest update
- Estimated end
- Not reported
Questions about this trial experience
What services are recorded for OPIS?
The 2026-10-09 snapshot links OPIS to 84 distinct CTIS trials. Recorded services include Trial master file management, Regulatory services, Clinical monitoring, Medical writing, among 21 recorded service labels. These are study-specific roles, not a complete or independently verified capability catalogue.
Which therapeutic areas and study phases are recorded for OPIS?
The most frequently recorded therapeutic areas are Immunology, Haematological Malignancies, Rheumatology, Solid Tumor Oncology. Recorded phases include Phase 3, Phase 2, Phase 1, Phase 4. Use the filters to inspect the supporting studies; missing tags are not evidence of absent experience.
In which countries are trials linked to OPIS conducted?
The linked trials record locations in 27 countries, including Italy, Spain, Germany, France, Poland. These are trial locations, not confirmed office locations or countries where OPIS delivered services.
What can this page tell me about OPIS's trial experience?
Browse 84 distinct trials with recorded roles, sponsor names, available study dates and links to CTIS source records. 4 trials have operational findings that can inform further due diligence. Trial counts and findings do not measure the provider’s performance or establish responsibility for study outcomes.
About this data & company names
One current approved profile per CTIS trial. Services reflect recorded roles, not a complete capability catalogue or a performance ranking. Missing tags mean the information was not recorded. Country tags describe trial locations, not the provider’s service territory.
Start is the reported EU start date; latest update is the CTIS publication date; estimated end is the reported global estimate, which may be in the past. Missing dates are shown as “Not reported”. Operational learnings describe the trial as a whole and do not establish the provider’s responsibility.
Clear service synonyms are grouped; otherwise the source label is retained. Service tags show the recorded roles for each trial. This page groups 1 recorded name variant under OPIS. Legacy brands remain separate unless explicitly matched in the name registry.
View recorded company names
- Opis S.r.l.