Institution identification

PURI

https://redirect.ema.europa.eu/resource/48288

Institution ID

48288

Institution full name and acronym

RTI Health Solutions (RTI-HS)

Institution countries

France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States

Type of institution

Not-for-profit

Institution website

ENCePP partner

Yes
Institution description
RTI is an independent non-for-profit research institute with a sixty-five-year history of leading research for public and private organizations. The RTI Health Solutions unit (RTI-HS) is focused on pharmaceutical and health research including pharmacoepidemiology/RWE,risk management,benefit-risk evaluation,pharmacovigilance,patient reported outcomes,health preference assessment and other. The experts in these areas are based in Europe and the U.S. Link to RTI-HS publications list: www.rtihs.org/publications
Institution details
Experience with collecting data directly from individual patients or respondents:
Yes
Interest in carrying out research that is funded by pharmaceutical companies:
Yes

Contact

Studies conducted by the institution

A Non-Interventional Post-Authorization Safety Study of Pfizer-BioNTech Bivalent COVID-19 Vaccine in the United States (US)
A post-authorisation/post-marketing observational study to evaluate the association between exposure to AZD1222 and safety concerns using existing secondary health data sources (COVID-19)
A Post-Authorization Safety Study of Golimumab in Ulcerative Colitis Using the Spanish ENEIDA Registry
ACCESS template protocol for safety of COVID-19 vaccines
Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures
An Observational Post-Authorisation Safety Study of Lesinurad Patients (SATURATES)
An Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers
An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)
An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States
Assessing the Incidence of Osteosarcoma Among Teriparatide Users Using Medicare Part D and State Cancer Registry Data (B3D-MC-GHBX Addendum 2.2)
Cilostazol Drug Utilisation Study
Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists
Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe
Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments
Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort
Comparison of the Risk of Acute Kidney Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
Comparison of the Risk of Acute Liver Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
Comparison of the Risk of Severe Complications of Urinary Tract Infections (UTI) Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study
Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients in Europe
Cross-sectional Study Evaluating the Effectiveness of Venetoclax Risk-Minimisation Measures Among Haematologists in Europe
Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International))
Drug Utilisation Study for Olodaterol
Drug utilisation study of Radium 223 under routine clinical practice in Europe (DIRECT)
Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe
Effectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full primary Covid-19 vaccination regimen (Covid Vaccines Effectiveness (CoVE))
Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey
Evaluation of potential off-label use of dabigatran etexilate in Europe
Evaluation of the Physician Education Component of the Ozurdex Risk Management Plan
Evaluation of the Use of Nepafenac in Selected European Populations
Extrapyramidal symptoms in patients treated with Abilify Maintena®: Cohort study with a 2-year follow-up using European automated healthcare databases
FINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic kidney disease and type 2 diabetes (FINEGUST)
Forteo/Forsteo post-approval osteosarcoma surveillance study
Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions
Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis (MELODIC Study)
Non-interventional post-authorization prospective cohort study evaluating the effectiveness of the additional risk minimization measures for filgotinib (Jyseleca®) use in patients with ulcerative colitis: a European multi registry-based study
Non-interventional, post-authorization prospective safety study of filgotinib in patients with moderately to severely active ulcerative colitis: a European multi registry-based study
Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Post-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with DPP-4 inhibitors (PASS renal, liver injury, infection, ketoacidosis)
Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury
Post-Authorisation Safety Study of Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 in Europe
Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries
Post-authorisation Safety Study of Tralokinumab Use in Pregnancy: An Observational Study Based on Electronic Healthcare Data
Post-authorisation Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide
Post-authorization Safety Program Using the Swedish National Registers—A Validation Study of Cardiovascular and Neoplasm Events in Users of PharmacologicalTreatments for Overactive Bladder
Post-Authorization Safety Program—Validation of the Clinical Practice Research Datalink for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder
Post-Authorization Safety Program—Validation of the Danish Data Resources for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder
Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder
Post-authorization Safety Study Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder : Core Common Protocol
Post-market clinical follow-up study – Retrospective evaluation of endothelial cell density and IOL explants related to the clinical use of AcrySof® CACHET® Phakic Lens in three European countries
Postauthorisation Safety Study (PASS) of Avatrombopag and Haematological Malignancies in Patients With Primary Immune Thrombocytopaenia
Postmarketing Noninterventional Study Evaluating the Risk of Endometrial Cancer in Women Who Have Been Prescribed Imvexxy®
PRECISE/Rates of bone fractures and survival in metastatic castration-resistant PRostate cancer (mCRPC) PatiEnts treated with Radium-223 in routine Clinical practIce in SwedEn
Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study (CLEAR)
Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR)
Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Risk of Melanoma Among Parkinson’s Disease Patients (TV1030-CNS-50024)
Risk of Mortality Associated With Pimavanserin Use Compared With Other Atypical Antipsychotics in Patients With Parkinson’s Disease–Related Psychosis
Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids (JOELLE)
Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids: Protopic JOint European Longitudinal Lymphoma and skin cancer Evaluation (JOELLE) Study
Risk of Upper Gastrointestinal Complications in Users of Nonsteroidal Anti-inflammatory Drugs
Safety Evaluation of Adverse Reactions in Diabetes - Comparative studies (SAFEGUARD)
Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies (SAFEGUARD)
Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment
Safety of Paxlovid During Pregnancy
Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA)
Study of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres (SALT-I)
Study on the association of uterine perforation and intrauterine device (IUD) expulsion with breastfeeding status at the time of IUD insertion and postpartum timing of IUD insertion in electronic medical record databases. A postmarketing requirement for Mirena (APEX IUD)
Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
TAK-771-4002: Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages