#

SERVICES

  • Design and medical writing of the protocol
  • Design and validation of the eCRF on our own web based platform (IC-eCRF)
  • EDC: IC-eCRF
  • Data management
  • Statistical analysis
  • Medical writing of the final report (Clinical Study Report) and of the scientific article (includes assistance in journal submission).
  • Classic services described below in international studies
  • Complete Clinical Trial Regulatory Services: MOH, IRB Submissions and Essential Documents Gathering
  • Project and Site Management Services
  • Clinical Monitoring Services
  • Local Medical Monitoring and Adverse Event Reporting and Management
  • Clinical Supply Management: Importation, Storage, Distribution and Destruction through authorized depots
  • Administrative and finance: Investigator / Site Contract Negotiation and payment administration
  • Local management of Pharmacovigilance: adverse event reporting, writing of standard operating procedures (SOPs), risk management plans (RMP), periodic safety update reports (PSUR), label update
  • Post authorization safety studies (PASS)
  • Active Pharmacovigilance Plans
MORE THAN TEN YEARS OF EXPERIENCE

IC-eCRF

Electronic data capture system

IC-eCRF® is a web based electronic data capture system that was developed for use in local late phase studies and is fully compliant with local GCP requirements for electronic data capture.

Main Features

  • Ease of Use: User friendly interface
  • Security: SSL environment, encryption and back-ups.
  • Data Quality: Validation and clarification systems (queries)
  • Relational database with the possibility of downloading ACCESS / EXCEL and compatibility with all statistical programs.
  • Audit trail

Our Experience

Experience and published studies

Our most relevant experience is in the areas of Oncology/Hematology, Rheumatology, Respiratory, Cardiology and Rare Diseases.

Below we include a list of some of some selected publications of projects in which we have participated.

Dubner S, et al. Effectiveness and safety of dabigatran in Latin American patients with atrial fibrillation: Two years follow up results from GLORIA-AF registry. Int J Cardiol Heart Vasc. 2020 Nov 3;31:100666. doi: 10.1016/j.ijcha.2020.100666. PMID: 33195793; PMCID: PMC7644920.

Dragonetti L et al. Prevalence of Cardiac Abnormalities in Fabry Disease: a Large CMR Study in Argentina. International Cardiovascular Forum Journal, [S.l.], v. 9, jan. 2017. ISSN 24093424.

Cozzani R, et al. ; ML29740 Investigators. Efficacy and safety profile of vismodegib in a real-world setting cohort of patients with advanced basal cell carcinoma in Argentina. Int J Dermatol. 2020 May;59(5):627-632. doi: 10.1111/ijd.14780. Epub 2020 Feb 7. PMID: 32034775.

Riveros D, et al. Single arm phase II multicenter study to evaluate efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) as first line of treatment in patients with chronic B-cell lymphocytic leukemia (CLL). La Prensa Médica Argentina 2016; Vol. 102 (5).

Ortiz E et al. Investigators of study ML20649. Assessment of quality of life in patients with metastatic breast cancer treated with oral and intravenous chemotherapy after relapse. La Prensa Médica Argentina 2016; Vol. 102 (6).

Babini A, et al. Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: Results from a 24-month OBSErve study in Argentina. Lupus. 2020 Oct;29(11):1385-1396. doi: 10.1177/0961203320947814. Epub 2020 Aug 14. PMID: 32791930; PMCID: PMC7536527.

Berenstein M, et al. Registry of intra-articular hyaluronic acid in the treatment of knee osteoarthritis in Argentina. Rev. Asoc. Argent. Ortop. Traumatol. 2019, vol.84, n.2, pp.122-128.

Montoya F. et al. Non-interventional multicenter study in patients with rheumatoid arthritis treated with tocilizumab. Rev. Argent. Reumatolg. 2017, vol.28, n.3, pp.23-28.

Menga G, et al.; DAAT.AR. study group. Prevalence of Alpha-1 Antitrypsin Deficiency in COPD Patients in Argentina. The DAAT.AR Study. Arch Bronconeumol. 2020 Sep;56(9):571-577. doi: 10.1016/j.arbres.2019.11.010. Epub 2019 Dec 27. PMID: 31889566.

Menga G, et al. Alpha-1 antitrypsin deficiency and spontaneous pneumothorax. Just a coincidence?. Medicina (B Aires). 2020;80(5):473-478. Spanish. PMID: 33048791.

Echazarreta AL et al. ; EPOC.AR study group. Prevalence of COPD in 6 Urban Clusters in Argentina: The EPOC.AR Study. Arch Bronconeumol. 2018 May;54(5):260-269. doi: 10.1016/j.arbres.2017.09.018. Epub 2017 Dec 6. PMID: 29221827.

Ripeau D et al. Switch from agalsidase beta to agalsidase alfa in the enzyme replacement therapy of patients with Fabry disease in Latin America. Medicina (B Aires). 2017;77(3):173-179. English. PMID: 28643672.

Organizations that have
trusted us

Resources

Information about
Research in Argentina

Local Regulation
Articles of Interest
Training in Clinical Research
Guide for Investigations with Human Beings. Ministry of Health in Argentina. Resolution 1480/11. Resolution that regulates all types of research (observational and experimental) in human beings. Download PDF (in Spanish)
Good Clinical Practice Regime for Clinical Pharmacology Studies. ANMAT Provision 6677/10. Provision that regulates phase 1-3 clinical pharmacology studies for the purpose of registration. Download PDF (in Spanish)
Regulation applicable to clinical studies of Medical Technology. ANMAT provision 969/97. Provision that regulates medical technology (medical device) studies in Argentina. Download PDF (in Spanish)

Contact

IC PROJECTS SRL - Main Contact
Dr Raúl Bozzo // MD
Tel (54911) 4816-2396
Fax (54911) 4816-5617
Oficinas
Av. Córdoba 1351, Floor 11
City of Buenos Aires
(C1055AAD), Argentina