Case studies

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.  


Medical device type

Study type

Activities covered

Digital prevention therapy for migraine

Clinical investigation 


Regulatory strategy, study design, Clinical Investigation Plan writing

Ophthalmology operative device

Post-marketing surveillance study

Clinical monitoring

Ophtalmology non-invasive treatment device for amblyobpia 

Clinical investigation

Site feasibility, KOL engagement, Regulatory submission preparation

COPD digitial therapy device

Clinical investigation

Data management

Back pain relieve digital therapy device

Clinical investigation

Data management

A small accelerometry based measurement unit

(intended use: assessment of sedentary worktime for office workers)

Post-marketing study

designed the study, co-wrote the protocol, oversaw data collection and wrote the code that analysed the data

A small accelerometry based measurement unit

(intended use: measurement of physical movements and calm periods during sleep)

Post-marketing study,

in collaboration with the sleep laboratory at Glostrup Hospital

designed the study, supervise students, reviewed enrolment plan, data management plan and statistical analysis

A sensor for Resistance Band Training

Clinical investigation (prior to obtaining the CE mark)


supervised study activities performed by Investigators and sub-Investigators, designed the study to evaluate the validity of the device and the superiority to regular elastic band training, co-wrote the protocol, oversaw the data collection and performed the statistical analysis

Therapautic area / indication

Clinical Trial 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


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