Case studies

In this selection of case studies, find out the bespoke, creative solutions we implemented
to turn project challenges into successes.

A First-In-Human trial of monoclonal antibody IMP in patients with Anti-Müllerian-Hormone-Receptor II (AMHRII) positive gynecological cancers

A First-In-Human trial of monoclonal antibody IMP in patients with Anti-Müllerian-Hormone-Receptor II (AMHRII) positive gynecological cancers

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Lung cancer patients treated with a new PD-1 IMP: A longitudinal, prospective, observational, multicentric study in France

Lung cancer patients treated with a new PD-1 IMP: A longitudinal, prospective, observational, multicentric study in France

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A Prospective study on an IMP PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

A Prospective study on an IMP PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

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Pain relief and protection of three self-treated dermatological foot conditions

Pain relief and protection of three self-treated dermatological foot conditions

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Pain relief and protection of three self-treated dermatological foot conditions

Pain relief and protection of three self-treated dermatological foot conditions

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Open, non-controlled, parallel cohorts, multicenter, phase 2a trial for the evaluation of the antitumor activity of an IMP single agent and in combination with chemotherapy in patients with locally advanced or metastatic colorectal cancer.

Open, non-controlled, parallel cohorts, multicenter, phase 2a trial for the evaluation of the antitumor activity of an IMP single agent and in combination with chemotherapy in patients with locally advanced or metastatic colorectal cancer.

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Derived cell ATMP implantation for the treatment of fecal incontinence: a multicentre, randomized, double-blind, placebo-controlled, parallel-group, dose-finding clinical study.

Derived cell ATMP implantation for the treatment of fecal incontinence: a multicentre, randomized, double-blind, placebo-controlled, parallel-group, dose-finding clinical study.

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A phase 1/2, open-label, safety, tolerability and preliminary efficacy study of implantation into one eye of an ATMP in patients with retinitis pigmentosa due to monogenic mutation

A phase 1/2, open-label, safety, tolerability and preliminary efficacy study of implantation into one eye of an ATMP in patients with retinitis pigmentosa due to monogenic mutation

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Long-Term Safety Evaluation of a Medicinal Product in Inherited Haematological Disorder in Europe

Long-Term Safety Evaluation of a Medicinal Product in Inherited Haematological Disorder in Europe

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Prevention & Treatment of a non-serious dermatological condition on the foot

Prevention & Treatment of a non-serious dermatological condition on the foot

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21 CFR Part 11 compliance
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bureau veritas certification icta