Running clinical trials in Latin America is both an amazing opportunity and a big challenge.

Being unaware of the different regulations, languages, time zones and cultural differences can hinder your progress and pose additional or unknown risks.

Distance, lack of experience or lack of specific knowledge in the region are no excuse for poor study oversight, which is a Sponsor obligation even when a local CRO is involved.

My mission consists in achieving 3 equally important objectives:

  • High Quality Data
  • Protection of Study Participants
  • GCP and Regulatory Compliance

Let me become your local partner in this enterprise so that it results in a successful and enjoyable experience!

About the
professional

My name is Laura Ardigó. I am a Family Physician with > 15 years of clinical research experience, having participated in over 40 clinical trials ranging from phases 1 to 4 in multiple therapeutic areas.

Find me on LinkedIn

After completing my medical residence I had my first contact with clinical research as a sub-investigator.

Already in the pharmaceutical industry I covered several positions over the years. I began working as data manager in oncology clinical trials, then evolved to a CRA role, and eventually became the project manager and clinical trial leader of local and global studies. Finally I spent some years as a clinical research manager, until I decided that I would work as a freelance clinical research consultant, providing advice, guidance, training and specialized support both to industry and research centers.

I was born and currently live in Buenos Aires, Argentina.

Services

for hire

Site support
services

  • Assessment and development of research sites
  • Staff training
  • Preparation for Audits
  • Mock Audits
  • Preparation for Inspections
  • Recruitment support
  • Development of Recruitment Materials
  • Development of Recruitment Plans

Sponsor support
services

  • Vendor Qualification and Oversight
  • CRO Qualification and Oversight
  • Clinical Trial Liaison
  • Site Selection
  • Site Monitoring
  • Project Management
  • Medical Monitoring
  • Audits

Clinical Research
Training

(On-side or Remote)

  • Research Ethics
  • Good Clinical Practice
  • Local & Regional Clinical Research Regulations
  • Informed Consent Process

Development and
Implementation
of SOPS

Review of processes in place, process design, SOP writing, team training and coaching during the implementation phase.

Medical
Writing

  • Protocol writing and correction
  • Informed Consent Forms and Patient Information
  • Manuscripts
  • Poster presentations
  • Video presentations

Coaching of
Research Staff

(On-side or Remote)

  • Clinical Research Coordinator (CRC)
  • Clinical Research Associate (CRA)

Summary of Clinical Trial Experience

THERAPEUTIC AREA, SUB INDICATION & DRUG CLASS PHASE JOB TITLE
Cardiovascular Disease - Newly Diagnosed Atrial Fibrillation N/A Clinical Site Monitor
Cardiovascular Disease - Acute Coronary Syndrome (apolipoprotein) III Clinical Oversight Manager (Regional)
Rheumatology - Dermatomyositis (immunoglobulin) III Clinical Oversight Manager (Country)
Rheumatology - Systemic Sclerosis (immunoglobulin) II Clinical Oversight Manager (Country)
Infectious Disease - COVID 19 hospitalized subjects (hyperimmune serum) II Clinical Site Monitor
Pulmonology/ Pulmonary Hypertension - COPD (inhaled treprostinil) III Clinical Site Monitor
Ophthalmology /Non Infectious Uveitis (intravitreal injections) III Oversight Clinical Site Monitor
THERAPEUTIC AREA, SUB INDICATION & DRUG CLASS PHASE JOB TITLE
Medical Devices - Peripheral Artery Disease IV Clinical Site Monitor - Regulatory Support
Neurology - Alzheimer Disease (neurotransmitter-targeted therapy) III Oversight Clinical Site Monitor
Infectious Disease – Acute Gastroenteritis (new combination of marketed products) III Project Manager
Infectious Disease – Pediatric Study/ Chagas Disease III Medical Monitor & Pharmacovigilance - Project Manager
Women’s Health - Infertility (biosimilar) N/A Central Monitor and Data Reviewer
Rheumatology - Rheumatoid Arthritis (biosimilar) N/A Central Monitor and Data Reviewer
Oncology - Breast Cancer (biosimilar) N/A Central Monitor and Data Reviewer
THERAPEUTIC AREA, SUB INDICATION & DRUG CLASS PHASE JOB TITLE
Oncohematology - Chronic Lymphocytic Leukemia IV Clinical Site Monitor – Regulatory Advisor – Medical Writer
Dermatology - Pyoderma gangrenosum (monoclonal antibody) II Site Coordinator – Research Advisor – Trainer
Ophthalmology - Uveitis (monoclonal antibody) III Clinical Operations Manager
Ophthalmology - Uveitis (monoclonal antibody) III Clinical Operations Manager
Ophthalmology - Uveitis – open label (monoclonal antibody) III Clinical Operations Manager
Women’s Health - Endometriosis Pain (GnRH antagonist) III Clinical Operations Manager
Metabolic Disease - Diabetic Nephropathy (renin-angiotensin system inhibitors) III Clinical Operations Manager
THERAPEUTIC AREA, SUB INDICATION & DRUG CLASS PHASE JOB TITLE
Oncology - Breast Cancer – Metastatic (PARP inhibitor) III Clinical Operations Manager
Oncology - Lung Cancer - 1st line therapy (PARP inhibitor) III Clinical Operations Manager
Infectious Disease - HCV (antiviral combo) III Clinical Operations Manager
Oncology - Glioblastoma – newly diagnosed (anti-EGFR monoclonal antibody drug conjugate) IIb/ III Clinical Operations Manager
Gynecologic Oncology - Ovarian Cancer (PARP inhibitor) III Clinical Operations Manager
Rheumathology - Osteoporosis (monoclonal antibody) III Patient Recruitment Specialist
Rheumatology - Osteoporosis + vertebral fracture (PTH analog) III Patient Recruitment Specialist
THERAPEUTIC AREA, SUB INDICATION & DRUG CLASS PHASE JOB TITLE
Women’s Health - Endometriosis (selective blocker of the progesterone receptor) II Patient Recruitment Specialist
Rheumatology - Rheumatoid Arthritis (Biosimilar) III Clinical Research Manager
Oncohematology - Non-Hodgkin Lymphoma (Biosimilar) III Clinical Research Manager
Oncology - Colorrectal Cancer – peri-operative setting (synthetic analog of vasopressin) II Clinical Research Manager - Clinical Site Monitor
Pediatric Oncology - Retinoblastoma & other refractory pediatric cancers (active immunotherapy) I Clinical Research Manager
Infectious Disease - HIV (antiretroviral therapy) II Clinical Research Manager
Oncology - Breast Cancer in surgical setting (similar to ADH) II Clinical Research Manager - Clinical Site Monitor
THERAPEUTIC AREA, SUB INDICATION & DRUG CLASS PHASE JOB TITLE
Women’s Health - Genital Warts (pro-apoptotic peptide) II/ III Clinical Trial Leader - Clinical Site Monitor
Gynecologic Oncology - Cervical Cancer in combination with chemotherapy & radiotherapy (pro-apoptotic peptide) II Clinical Research Manager - Clinical Site Monitor
Oncology - Lung Cancer, advanced stages (active immunotherapy) III Clinical Site Monitor - Clinical Trial Leader (Global)
Oncology - Lung Cancer, advanced stages (active immunotherapy) II Clinical Site Monitor
Cardiology - Pediatric study/ Systemic To Pulmonary Artery Shunt Palliation (Clopidogrel) III Clinical Site Monitor
Infectious Disease - HIV treatment naïve population (antiretroviral therapy) III Clinical Site Monitor
Infectious Disease - HIV (antiretroviral therapy) III Clinical Site Monitor
THERAPEUTIC AREA, SUB INDICATION & DRUG CLASS PHASE JOB TITLE
Metabolic Disease - Diabetes (synthetic ligand for peroxisome proliferator-activated receptors (PPARs)) III Clinical Site Monitor
Metabolic Disease - Diabetes (dipeptidyl peptidase-4 inhibitor) III Clinical Site Monitor
Oncology - Breast Cancer in advanced stages (semi-synthetic analog of epothilone B) III Data Manager - Co-monitoring
Rheumatology - Rheumatoid Arthritis (Biologic) III Data Manager
Rheumatology - Osteoporosis - selective estrogen receptor modulator (SERM) III Sub-Investigator
Rheumatology - Osteoporosis + vertebral fracture (PTH analog) III Sub-Investigator
Rheumatology - Osteoporosis - selective estrogen receptor modulator (SERM) III Sub-Investigator

Cardiovascular Disease - Newly Diagnosed Atrial Fibrillation

Phase N/A

Clinical Site Monitor

Cardiovascular Disease - Acute Coronary Syndrome (apolipoprotein)

Phase III

Clinical Oversight Manager (Regional)

Rheumatology - Dermatomyositis (immunoglobulin)

Phase III

Clinical Oversight Manager (Country)

Rheumatology - Systemic Sclerosis (immunoglobulin)

Phase II

Clinical Oversight Manager (Country)

Infectious Disease - COVID 19 hospitalized subjects (hyperimmune serum)

Phase II

Clinical Site Monitor

Pulmonology/ Pulmonary Hypertension - COPD (inhaled treprostinil)

Phase III

Clinical Site Monitor

Ophthalmology /Non Infectious Uveitis (intravitreal injections)

Phase III

Oversight Clinical Site Monitor

Medical Devices - Peripheral Artery Disease

Phase IV

Clinical Site Monitor - Regulatory Support

Neurology - Alzheimer Disease (neurotransmitter-targeted therapy)

Phase III

Oversight Clinical Site Monitor

Infectious Disease – Acute Gastroenteritis (new combination of marketed products)

Phase III

Project Manager

Infectious Disease – Pediatric Study/ Chagas Disease

Phase III

Medical Monitor & Pharmacovigilance - Project Manager

Women’s Health - Infertility (biosimilar)

Phase N/A

Central Monitor and Data Reviewer

Rheumatology - Rheumatoid Arthritis (biosimilar)

Phase N/A

Central Monitor and Data Reviewer

Oncology - Breast Cancer (biosimilar)

Phase N/A

Central Monitor and Data Reviewer

Oncohematology - Chronic Lymphocytic Leukemia

Phase IV

Clinical Site Monitor – Regulatory Advisor – Medical Writer

Dermatology - Pyoderma gangrenosum (monoclonal antibody)

Phase II

Site Coordinator – Research Advisor – Trainer

Ophthalmology - Uveitis (monoclonal antibody)

Phase III

Clinical Operations Manager

Ophthalmology - Uveitis (monoclonal antibody)

Phase III

Clinical Operations Manager

Ophthalmology - Uveitis – open label (monoclonal antibody)

Phase III

Clinical Operations Manager

Women’s Health - Endometriosis Pain (GnRH antagonist)

Phase III

Clinical Operations Manager

Metabolic Disease - Diabetic Nephropathy (renin-angiotensin system inhibitors)

Phase III

Clinical Operations Manager

Oncology - Breast Cancer – Metastatic (PARP inhibitor)

Phase III

Clinical Operations Manager

Oncology - Lung Cancer - 1st line therapy (PARP inhibitor)

Phase III

Clinical Operations Manager

Infectious Disease - HCV (antiviral combo)

Phase III

Clinical Operations Manager

Oncology - Glioblastoma – newly diagnosed (anti-EGFR monoclonal antibody drug conjugate)

Phase IIb/ III

Clinical Operations Manager

Gynecologic Oncology - Ovarian Cancer (PARP inhibitor)

Phase III

Clinical Operations Manager

Rheumathology - Osteoporosis (monoclonal antibody)

Phase III

Patient Recruitment Specialist

Rheumatology - Osteoporosis + vertebral fracture (PTH analog)

Phase III

Patient Recruitment Specialist

Women’s Health - Endometriosis (selective blocker of the progesterone receptor)

Phase II

Patient Recruitment Specialist

Rheumatology - Rheumatoid Arthritis (Biosimilar)

Phase III

Clinical Research Manager

Oncohematology - Non-Hodgkin Lymphoma (Biosimilar)

Phase III

Clinical Research Manager

Oncology - Colorrectal Cancer – peri-operative setting (synthetic analog of vasopressin)

Phase II

Clinical Research Manager - Clinical Site Monitor

Pediatric Oncology - Retinoblastoma & other refractory pediatric cancers (active immunotherapy)

Phase I

Clinical Research Manager

Infectious Disease - HIV (antiretroviral therapy)

Phase II

Clinical Research Manager

Oncology - Breast Cancer in surgical setting (similar to ADH)

Phase II

Clinical Research Manager - Clinical Site Monitor

Women’s Health - Genital Warts (pro-apoptotic peptide)

Phase II/ III

Clinical Trial Leader - Clinical Site Monitor

Gynecologic Oncology - Cervical Cancer in combination with chemotherapy & radiotherapy (pro-apoptotic peptide)

Phase II

Clinical Research Manager - Clinical Site Monitor

Oncology - Lung Cancer, advanced stages (active immunotherapy)

Phase III

Clinical Site Monitor - Clinical Trial Leader (Global)

Oncology - Lung Cancer, advanced stages (active immunotherapy)

Phase II

Clinical Site Monitor

Cardiology - Pediatric study/ Systemic To Pulmonary Artery Shunt Palliation (Clopidogrel)

Phase III

Clinical Site Monitor

Infectious Disease - HIV treatment naïve population (antiretroviral therapy)

Phase III

Clinical Site Monitor

Infectious Disease - HIV (antiretroviral therapy)

Phase III

Clinical Site Monitor

Metabolic Disease - Diabetes (synthetic ligand for peroxisome proliferator-activated receptors (PPARs))

Phase III

Clinical Site Monitor

Metabolic Disease - Diabetes (dipeptidyl peptidase-4 inhibitor)

Phase III

Clinical Site Monitor

Oncology - Breast Cancer in advanced stages (semi-synthetic analog of epothilone B)

Phase III

Data Manager - Co-monitoring

Rheumatology - Rheumatoid Arthritis (Biologic)

Phase III

Data Manager

Rheumatology - Osteoporosis - selective estrogen receptor modulator (SERM)

Phase III

Sub-Investigator

Rheumatology - Osteoporosis + vertebral fracture (PTH analog)

Phase III

Sub-Investigator

Rheumatology - Osteoporosis - selective estrogen receptor modulator (SERM)

Phase III

Sub-Investigator

Let's work together

Contact information