Afinitor Disperz® (everolimus) is indicated for the treatment of tuberous sclerosis complex (TSC) associated partial-onset seizures in adult and paediatric patients.
NORMA conducts clinical trials, phase I–IV, for international pharmaceutical and biotech companies, through a network of subsidiaries in the Nordic and Baltic countries.
Contract research organisation for clinical trials in northern Europe
We work together as an enthusiastic and service-orientated team to deliver outstanding work. Our flexibility and professionalism have earned us recognition among our clients and is reflected in substantial repeat business.
A recent survey of customer perception among our large customers showed that ‘high quality’ and ‘flexibility’ are the primary reasons for choosing NORMA as their monitoring company. In additon, ‘project team devoted to study’ and ‘geographic reach / presence’ are important factors.
The working climate at NORMAS’s offices is positive and friendly and we strive to keep a low staff turnover.
CRO for clinical trials in various therapeutic areas
NORMA has over 90 employees, including experienced project managers, clinical research associates and clinical trials assistants. NORMA has 19 years of experience and has participated in more than 300 clinical trials across a wide range of therapeutic areas, including:
- Cardiovascular disorders: AMI, angina pectoris, hypertension, PAD and ACS
- CNS: depression, schizophrenia, Alzheimer’s dementia, epilepsy, MS, Parkinson’s disease and pain
- Dermatology: psoriasis and PLE / PMLE
- Endocrinology: diabetes, HRT, oral contraceptives and osteoporosis
- Infection: HIV, vaccines and herpes zoster
- Gastrointestinal disorders: ulcerative colitis, Crohn’s disease and collagenous colitis
- Oncology: breast cancer, prostate cancer, head-and-neck, leukaemia, solid tumours and malignant melanoma
- Immunology: arthritis and osteoarthrosis
- Medical devices: cardiac stents, urethral catheters and suction bags
NORMA has a strong client base with 80% repeat business due to a high level of quality. NORMA has a vast and valid network of potential investigators, and is a flexible and co-operative business partner.
Contract research services for clinical trials
NORMA staff work according to client or NORMA SOPs:
- Recruitment and evaluation of investigators
- GCP training of investigators and site staff
- Submissions to medicines agencies and ethics committees
- Organisation of investigator meetings
- Protocol writing
- CRF design
- Regular monitoring of phase I-IV trials
- Reporting to sponsor
- Medical monitoring
- Outsourcing of CRAs and CTAs
NORMA covers the entire Nordic and Baltic region in northern Europe, with offices in Denmark, Finland, Norway, Sweden, Estonia and Lithuania.
All these countries follow the general EU guidelines for approval of clinical trials; however, there are additional national – or even local – guidelines to follow. The local offices work competently and efficiently according to guidelines to meet and surpass client expectations.
Austedo™ (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT 2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.
Sublocade™ (buprenorphine extended-release) is a partial agonist indicated for the treatment of moderate-to-severe opioid use disorder (OUD) in adults.
Aliqopa (copanlisib) is a novel intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL).
Vosevi™ (Sofosbuvir/Velpatasvir/Voxilaprevir) is a direct-acting antiviral (DAA) indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotypes one to six.
Baxdela™ (delafloxacin) is a fluoroquinolone antibiotic drug indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). The drug was discovered and developed by Melinta Therapeutics in partnership with Ligand Pharmaceuticals.
ruxima™ (rituximab) is the first biosimilar monoclonal antibody (mAb) approved for the treatment of haematological cancers, including diffuse large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukaemia, and rheumatoid arthritis, as well as granulomatosis with polyangiitis and microscopic polyangiitis.
Alunbrig (brigatinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).