Last updated on: 14/07/2023
Name of organisation
1) Department/Research groupPharmacoepidemiology & Risk Management
2) Organisation/affiliationRTI Health Solutions
Short Name in the inventoryRTI-HS
Administrative Contact
Title Ms
Last name Franzoni Grau
First name Carla
Address line 1Av. Diagonal, 605, 9-1
Address line 2
Address line 3
CityBarcelona
Postcode08028
CountrySpain
Phone number (incl. country code)34932417776
Alternative phone number
Fax number (incl. country code)34937608507
Scientific Contact
Title Dr
Last name Perez-Gutthann
First name Susana
Address line 1Av. Diagonal, 605, 9-1
Address line 2
Address line 3
CityBarcelona
Postcode08028
CountrySpain
Phone number (incl. country code)34932417760
Alternative phone number
Fax number (incl. country code)34937608507
Alternative Scientific Contact
Title Dr
Last name Arana
First name Alejandro
Address line 1Av. Diagonal, 605, 9-1
Address line 2
Address line 3
CityBarcelona
Postcode08028
CountrySpain
Phone number (incl. country code)34-93 362 2805
Alternative phone number
Fax number (incl. country code)34937608507
2. 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
3. Category
Charity or non-profit organisation
4. Available resources
In houseVia Contacts/Network
Epidemiologist/Pharmacoepidemiologist
Yes
Yes
Statistician
Yes
Yes
Clinician
Yes
Yes
Clinical Pharmacologist
Yes
Yes
Pharmacist
Yes
Yes
Geneticist/Pharmacogeneticist
Yes
No
IT specialist
Yes
Yes
Ethics expertise
Yes
Yes
Legal expertise
Yes
Yes
Regulatory expertise
No
Yes
Patient & HCP surveys and patient reported outcomes
Yes
No
Health Preference assessment
Yes
No
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Cardiovascular diseases
Congenital Malformations
Devices
Disorders of the central nervous system
Endocrine disorders
Eye disorders
Gastrointestinal tract
Geriatrics
Gynaecology
Immunological products and vaccines
Immunosuppression
Infectious diseases
Liver disease
Malignant disease
Musculoskeletal and joint diseases
Nutrition and blood
Osteoporosis
Paediatrics
Pregnancy
Psychiatry
Renal impairment
Respiratory diseases
Skin disorders
Urinary tract disorders
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
Case Control Study
Drug Utilisation
Meta-Analysis
Risk minimization evaluation surveys and patient, HCP & other preference assessment studies
External RWE arms, RWE label changes
7. Experience in collecting data directly from individual patients/respondents
Number of Studies
Greater than 5
Number of patients/respondents involved in the study(ies)
Between 150 and 1499
Between 1500 and 14999
Greater than 15000
8. Access to data collection resources
Capacity to conduct face-to-face interviews
Yes
In a clinic
Yes
In the community
Yes
Electronic data capture systems
Yes
System used:
System selected for each study
Interactive voice response systems
No
Call centre
No
9. Experience in secondary research and meta-analysis
Yes
10. Work with existing data resources in the past 3 years
Name of data resourceNo. of studies
CPRD/THIN, ISD Memo, UK21
Regions of Catalonia and Aragón, Spain10
PHARMO Institute for Drug Outcomes Research, Netherlands12
National Registries Nordic Countries, Denmark, Sweden19
GePaRD10
11. Registries established by centre
Drug RegistryDrug class = osteoporosis (US), Drug class = IBS treatment (US) (Closed)
Disease RegistryDisease area = individuals attempting to quit smoking (in EU, Canada, and US) (Closed)
Other Osteosarcoma cases who had been exposed to a specific medication in Norway, Denmark, Sweden, Finland, US (Closed)
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Networks registered with ENCePP
SIGMA
VAC4EU
14. Interest in research opportunities which are funded
By pharmaceutical companies
By charities
By government
By research councils
By EU funding schemes
15. Interest in contract research only if free to publish results
Yes
16. Selected publications of the last 5 calendar years
ReferenceLink to web-publication
Layton, J.B., Forns, J., McQuay, L.J. et al. Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study. Drug Saf 46, 195–208 (2023). https://doi.org/10.1007/s40264-022-01260-6
Danysh, H.E., Johannes, C.B., Beachler, D.C. et al. Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting. Drug Saf 46, 175–193 (2023). https://doi.org/10.1007/s40264-022-01262-4
Rebordosa C, Plana E, Rubino A, Aguado J, Martinez D, Lei A, Daoud S, Saigi-Morgui N, Perez-Gutthann S, Rivero-Ferrer E. Risk Assessment of Acute Myocardial Infarction and Stroke Associated with Long-Acting Muscarinic Antagonists, Alone or in Combination, versus Long-Acting beta2-Agonists. Int J Chron Obstruct Pulmon Dis. 2022;17:1715-1733https://doi.org/10.2147/COPD.S363997
Arana A, Pottegård A, Kuiper JG, Booth H, Reutfors J, Calingaert B, Lund LC, Crellin E, Schmitt-Egenolf M, Kaye JA, Gembert K, Rothman KJ, Kieler H, Dedman D, Houben E, Gutiérrez L, Hallas J, Perez-Gutthann S. Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and Pimecrolimus: Final Results from the Extension of the Cohort Study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE). Clin Epidemiol. 2021;13:1141-1153https://doi.org/10.2147/CLEP.S331287
Fortuny J, von Gersdorff G, Lassalle R, Linder M, Overbeek J, Reinold J, Toft G, Timmer A, Dress J, Blin P, Droz-Perroteau C, Ehrenstein V, Franzoni C, Herings R, Kollhorst B, Moore N, Odsbu I, Perez-Gutthann S, Schink T, Rascher K, Rasouliyan L, Rothman KJ, Saigi-Morgui N, Schaller M, Smits E, Forstner M; Intravenous Iron Consortium, Bénichou J, Bircher AJ, Garbe E, Rampton DS, Gutierrez L. Use of intravenous iron and risk of anaphylaxis: A multinational observational post-authorisation safety study in Europe. Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1447-1457. doi: 10.1002/pds.5319https://onlinelibrary.wiley.com/doi/10.1002/pds.5319
