Experience

 

Brillance Sp. z o.o. has supported pharmaceutical, biotechnology and medical device Sponsors in conducting clinical research in Poland, the Czech Republic and Slovakia since 2004.

 

Brillance experience: 268+ clinical projects, Phases I–IV, medical device experience since 2008, 47 rare-disease protocols and active delivery in three countries.

 

All Phase I projects have been delivered in patient populations at specialist hospital sites. Our experience also includes an advanced therapy medicinal product (ATMP) project.

Portfolio structure by therapeutic area

Percentage share of projects across the main therapeutic groups - cumulative since 2004.

portfolio
since 2004
 Oncology and hemato-oncology25%  Cardiology15%  Respiratory diseases and allergy14%  Neurology and psychiatry11%  Other therapeutic areas9%  Metabolic and endocrine7%  Vaccines and infectious diseases7%  Rheumatology6%  Gastroenterology, hepatology and nephrology6%
Other areas include immunology, non-malignant hematology, ENT, gynecology, ophthalmology, dermatology, orthopedics, dental surgery and transplantology.

Experience since 2021

Percentage share of the main therapeutic groups in projects initiated since 2021.

projects
since 2021
 Neurology and psychiatry50%  Oncology and hemato-oncology19%  Cardiology9%  Gastroenterology, hepatology and nephrology9%  Other therapeutic areas13%
Half of the more recent portfolio is in neurology and psychiatry, including ALS, Alzheimer’s disease, multiple sclerosis and myasthenia gravis.

Development phases across the portfolio

Distribution of medicinal product projects with available, comparable phase information.

Phase
Portfolio since 2004
Projects since 2021
I / I–II
5%
7%
II
22%
28%
II–III
3%
7%
III
63%
48%
IV
7%
10%
27%
Phase I–II in the cumulative portfolio
 
34%
Phase I–II in projects initiated since 2021
 

Early-phase experience spans oncology and hemato-oncology, neurology, rheumatology, respiratory and allergy, gastroenterology, hepatology, nephrology and cardiology.

Selected recruitment outcomes: Poland, the Czech Republic and Slovakia

 

Phase III CLL study
130+
patients
Phase III cardiovascular outcomes study
800+
patients
Phase III acute coronary syndrome study
650+
patients
Phase III COPD study
600+
patients

Therapeutic experience and indications

 

24
protocols in rare oncology indications
23
protocols in non-oncology rare-disease indications

Phase labels refer to medicinal product trials. Medical device experience is presented separately.

Oncology
Phases I–III
  • Breast cancer
  • Colorectal cancer
  • Prostate cancer
  • Endometrial cancer
  • Head and neck cancers
  • Liver cancer
  • Hepatocellular carcinoma (HCC)
  • Renal cell carcinoma (kidney cancer)
  • Pancreatic cancer
  • Melanoma
  • Lung cancer vaccine
  • Non-small cell lung cancer (NSCLC)
  • Cancers of the tongue and soft palate
  • Oral cavity and soft palate cancer
  • Cutaneous squamous cell carcinoma (cSCC)
  • Squamous cell carcinoma of the head and neck (SCCHN)
  • Non–muscle-invasive bladder cancer (NMIBC)
Hemato-oncology
Phases I–IV
  • Chronic myeloid leukemia (CML)
  • Chronic lymphocytic leukemia (CLL)
  • Myelodysplastic syndromes (MDS)
  • Multiple myeloma (MM)
  • Waldenström macroglobulinemia (WM)
  • Lymphoplasmacytic lymphoma (LPL)
  • Non-Hodgkin lymphomas
  • Follicular lymphoma (FL)
  • Small lymphocytic lymphoma (SLL)
  • Marginal zone lymphoma (MZL)
  • Mantle cell lymphoma (MCL)
  • Diffuse large B-cell lymphoma (DLBCL)
  • High-grade B-cell lymphoma (HGBL)
  • Primary CNS lymphoma (PCNSL)
  • Secondary CNS lymphoma (SCNSL)
  • Primary cutaneous diffuse large B-cell lymphoma (DLBCL)
Cardiology
Phases I–IV
  • Arterial hypertension (including pediatric)
  • Pulmonary hypertension
  • Hyperlipidemia
  • Atherosclerosis in ischemic heart disease (IHD)
  • Coronary artery disease (CAD)
  • Ischemic heart disease (IHD)
  • Angina pectoris
  • Acute coronary syndrome (ACS)
  • ACS in patients with type 2 diabetes (T2D)
  • Myocardial infarction (MI)
  • Myocardial infarction with cardiogenic shock (MI + CS)
  • Percutaneous coronary intervention (PCI)
  • Revascularization
  • Chronic heart failure
  • Acute heart failure
  • Newly diagnosed atrial fibrillation
  • Anticoagulation therapy in atrial fibrillation
  • Mitral regurgitation
  • Transcatheter mitral valve repair
  • Myocardial injury after non-cardiac surgery (MINS)
Neurology
Phases I–III
  • Alzheimer’s disease (AD)
  • Amyotrophic lateral sclerosis (ALS)
  • Epilepsy
  • Multiple sclerosis (MS), including pediatric relapsing–remitting disease (RMS)
  • Huntington’s disease (HD)
  • Myasthenia gravis (MG)
  • Postherpetic neuralgia (PHN)
  • Pediatric mitochondrial disease
Psychiatry
Phases II–IV
  • Bipolar disorder
  • Depression
  • Premenstrual dysphoric disorder (PMDD)
Metabolism / Endocrinology / Diabetology
Phases II–IV
  • Type 2 diabetes (T2D)
  • Type 1 diabetes (T1D)
  • Impaired glucose tolerance (IGT)
  • Cushing’s syndrome
  • Hypopituitarism / growth hormone deficiency (GHD)
Nephrology
Phases II–III
  • Anemia in chronic kidney disease (CKD)
  • Chronic kidney disease (CKD)
  • End-stage renal disease (ESRD)
Respiratory Diseases
Phases II–III
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Cystic fibrosis
Allergology / Immunology
Phases II–IV
  • Allergic rhinitis (AR)
  • House dust mite–induced allergic rhinitis
  • Allergic rhinitis with or without asthma (children and adults)
  • Allergic rhinitis and conjunctivitis
  • Allergic rhinitis and conjunctivitis with asthma
  • Bronchial asthma
  • Eosinophilic asthma
  • House dust mite–induced asthma
  • Timothy grass pollen allergy
  • Birch pollen allergy (pediatric population)
  • Hereditary angioedema (HAE)
  • Primary immunodeficiencies / virology
Otolaryngology (ENT)
Phases II–III
  • Sinusitis / rhinosinusitis
  • Otitis media (pediatric)
  • Vertigo / dizziness (lightheadedness)
  • Tinnitus
Gastroenterology / Hepatology
Phases II–IV
  • Crohn’s disease (CD)
  • Postoperative ileus (POI)
  • Exocrine pancreatic insufficiency 
  • Liver injury
  • Primary sclerosing cholangitis (PSC)
  • Nonalcoholic steatohepatitis (NASH)
Rheumatology
Phases I–IV
  • Rheumatoid arthritis (RA)
  • Osteoporosis / osteopenia (postmenopausal)
  • Juvenile idiopathic arthritis (JIA)
  • Gout
  • Cutaneous lupus
  • ANCA-associated vasculitis
Vaccines / Infectious Diseases
Phases II–III
  • Influenza vaccine (including pediatric population)
  • Combined measles, mumps, rubella, and varicella vaccine (MMRV)
  • Pneumococcal vaccine
  • Herpes zoster (shingles) vaccine
  • Herpes zoster in patients after bone marrow transplantation
  • Hepatitis B virus infection (HBV)
  • Hepatitis C virus infection (HCV)
  • Antiviral therapies (influenza)
  • Pneumonia
Dermatology
Phase III
  • Distal lateral subungual onychomycosis (DLSO)
  • Nail psoriasis
Gynecology
Phases II–III
  • Mastodynia
  • Recurrent vulvovaginal candidiasis (RVVC)
Hematology
Phases III–IV
  • Anticoagulant therapies
  • Hemophilia A
Ophthalmology
Phases II–III
  • Glaucoma
  • Choroidal neovascularization secondary to age-related macular degeneration (AMD)
Orthopedics / Surgery
Phase I (ATMP) + devices
  • Femoral stem revision
  • Degenerative spondylolisthesis
Transplantology / Dentistry
Phases III–IV + devices
  • Kidney, heart and liver transplantation
  • Third molar extraction / post-extraction pain

Medical devices - 11 clinical investigations since 2008

 

Our documented experience includes 11 medical device clinical investigations delivered since 2008, including complex and high-risk projects. We support MedTech solutions from pilot projects through pivotal and post-market investigations, with a strong focus on data quality, efficient communication and inspection readiness.

 

Example areas of medical device clinical investigations
  • Cardiology (including interventional cardiology and devices) – e.g., revascularization, pulmonary hypertension, transcatheter mitral valve repair
  • Orthopedics / surgery - e.g., femoral stem revision procedures
  • Diagnostics and technologies supporting clinical decision-making
  • Pilot, pivotal and post-market investigations
How we support Sponsors
  • End-to-end study support from initiation through close-out (start-up → conduct → close-out)
  • Work performed in accordance with ISO 14155 (GCP for medical devices) and an “inspection-ready” approach
  • Understanding of MedTech project specifics: clinical pathway, procedure organization, and site realities
  • Site selection based on actual procedural volumes and patient access, with efficient site activation
  • Strong focus on data and documentation quality and practical training for site teams and CRAs
  • Flexible resourcing, tailored project support and an experienced CRA team