NAVIGATING COMPLEX TRIALS TO CLEAR SUCCESS
OUR CUMULATIVE EXPERIENCE
CASE STUDY 1
Phase 1/2 study with Castration-Resistant Prostate Cancer (CRPC) patients who have failed first- and second-line treatment.
- The study consisted of two parts, dose escalation phase followed by dose expansion portion. Due to a narrow target patient population the approximately 30 sites in four countries were set up, which substantially added to the complexity of the study logistics.
- One of the logistical challenges was careful management of enrolment slots that needed to be allocated to specific patients in order to fill a cohort in a timely manner and subsequently arrange for a Safety Review Meeting which would then allow to open a following cohort.
- We implemented a robust process that fit the site set-up and sites´ geographical location. Extremely close communication was absolutely necessary to achieve this and the team was instrumental in setting the appropriate communication lines with CRAs and the Investigators.
- IMP had to be carefully managed due to a relatively high number of sites for this study phase. Discovered errors on the IMP vendor site were promply corrected and mitigated using excellent negotiation skills.
- The trial was audited with no major findings.
CASE STUDY 2
Clinical Investigation Plan writing and design of a clinical investigation to evaluate safety and performance of a digital therapeutic for migraine prevention (medical device under MDR)
- We have established a team consisting of a statistician with medical background, a medical wirter, a regulatory expert with experience in migraine under leadership of an experienced clinical project manager.
- One of the challenges was to ensure the communication between the sponsor´s two medical experts ands also the individuals responsible for data handling.
- This was achieved through frequent comment resolution meetings and allowing for careful consideration of the uncertain portions of the investigation management and taking time which data will be collected with which modality.
- The Clinical Investigation Plan was reviewed by a native English speaker with extensive in clinical research in order to ensure linguistic accuracy.
Therapeutic area / Indication | Development phase | Activities covered |
Oncology / Prostate cancer | Phase 1/2 | Clinical trial management, oversight of all functional areas and trial activities, audit participation |
Oncology / Multiple indications | RWE | Clinical project management, site agreements, site feasibility |
Oncology / Prostate cancer | Preparation for FIH trial | Regulatory strategy, Investor presentation creation, Business plan writing |
Oncology / Mucositis | Preparation for FIH trial | Regulatory strategy |
Immunology / Atopic dermatitis | Phase 2 | Clinical trial design management, clinical trial management, coordination of all functional areas and management of multiple vendors |
Immunology / Ulcerative colitis | Phase 2 | Clinical trial management and vendor oversight, monitoring oversight |
Immunology / Rheumatoid arthritis | Phase 2 | Clinical trial design management, clinical trial management, coordination of all functional areas and management of vendors |
Rare disease / Beta-thalassemia (Gene therapy) | PASS (EMA commitment study) | Monitoring, regulatory and ethics submissions |
Rare disease / Congenital Disorders of Glycosylation | RWE | Project management, monitoring oversight, Ethics Committee submission management, site agreement negotiation management |
Rare disease / Paroxysmal nocturnal haemoglobinuria | Phase 3 | Regulatory inspection preparatory audit and inspection follow-up |
Rare disease / Congenital Hyperinsulinism | Phase 2b | Clinical monitoring, site contracts |
Neurology / Rare form of epilepsy | Phase 2 | Regulatory submissions, Ethics Committee submissions, clinical monitoring, site contracting |
Medical device type | Study type | Activities covered |
Preventative migraine therapy (digital therapeutic) | Clinical investigation | Regulatory strategy, study design, Clinical Investigation Plan writing |
Ophthalmology operative device | Post-marketing surveillance study | Clinical monitoring |
Ophthalmology non-invasive treatment device for amblyopia | Clinical investigation | Site feasibility, KOL engagement, Regulatory submission preparation |
COPD digitial therapy device | Clinical investigation | Data management |
Back pain relief digital therapy device | Clinical investigation | Data management |
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