The clinical portfolio lists some of our clinical compliance, research associate and study site coordination engagements. Client references are not included for confidentiality reasons.
Clinical compliance assistance, management, development and trainings.
- Assisting in writing, reviewing and updating Standard Operation Procedures (SOP) for all clinical trial activities to comply with Good Clinical Practice (GCP).
- Introduce procedures to new staff and provide training.
- Revision of protocols and assistance in the development of Case Report Form (CRF).
- Set up of study manuals and logistic procedures.
- Consultancy on study nurse activities and procedures.
- Project management.
- Training for new employees on Introduction to Clinical Research.
- Course ICH-GCP for investigators and clinical site personnel.
Clinical research monitoring (of phase III, IIIb and IV trials), coordination and trainings.
- Monitoring phase IIIb-IV studies in the field of hepatitis C.
- Training of monitors in multinational phase IIIb IV studies in the field of hepatitis C.
- Monitoring phase IIIb IV studies in the field of hepatitis C.
- Monitoring multi-centre phase III study in the field of infectious diseases.
- Monitoring of multi-centre phase IV studies in the field of Central Nervous System (CNS).
- Coordination and supervision of monitors in a multinational phase III study in the field of oncology.
- Electronic Data Capture: CTMS, RAVE, Phase Forward, Inform.
Study site coordination, data management, study nursing, trainings.
- Phase II clinical trial in rheumathoid arthritis.
- Study site coordinator for Hepatitis C phase II and III trials.
- Study coordinator for clinical trials in gastro-oncology.
- Responsible for data review and data entry of a registry study in the domains of lung-embolism.
- Study nurse for phase II and III trials Gastro-enterology and training new study nurses.
- Study site coordinator for lung cancer (NSCLC and SCLC).
- Study nurse for Hepatitis B and C phase II and II trials and training new study nurses.
Therapeutic areas
In our engagements we gained experience in the following therapeutic areas:
Infectious Diseases
Oncology
- Hepatitis C
- Clostridium
- Hepatitis B
Oncology
- Breast Cancer
- Lung Cancer
- Kaposi’s Sarcoma
Ophthalmology
Gastro-intestinal
- Uveitis
Gastro-intestinal
- Crohn’s disease
- Ulcerative Colitis
- NASH
- Fistula’s
Cardiovascular
Central Nervous System
- Hyper-cholesterolemia
- Erectile dysfunction
- Lung embolism
Central Nervous System
- Depression
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The descriptions on our portfolio projects are brief and intentionally do not reveal client references. For more information and background, please contact us.