CLINICAL RESEARCH CONSULTANCY AND SERVICES
Flexible and trustworthy solutions for your clinical trials
How can I help you?
Management
Project Management
People management (to cover medical or maternity leave)
Development of study-specific monitoring guides and tools
Development and delivery of training: for CRAs and/or sites (online and face-to-face)
Development of proposals
Quality
Site Audits
Support on CAPA development
Quality visits (non-audit): review of site performance, suggestions for improvement and site training
SOP development (site and sponsor)
File management (quality checking, preparation for archiving) for both company files and/or site files
Oversight
CRA Oversight visits: review CRA’s performance
Site Oversight visits: review site’s performance
Recruitment Oversight: frequent site contacts to oversee recrutiment activities and propose strategies
Recrutiment visits: independent view of site performance and proposal of actions to boost recruitment
Monitoring
Full-service site monitoring (in-house/on-site): all types of monitoring visits from site selection to close-out (Blinded & Unblinded)
On-demand support:
- Interim analysis/ Database lock
- Reducing backlog (SUSAR submission and filing, data review, file review, IP accountability)
- Re-monitoring
Fast and Easy Solutions When:
You want to conduct your studies in LATAM and do not plan to subcontract a CRO.
You need an independent auditor to cover LATAM countries.
You need extra resources to reach a project milestone.
Project scope was extended but you do not plan to increase your headcount.
You need to cover employee leaves.
Urgent project tasks need to be completed and you had an unantecipated staff shortage.
EXPAND YOUR REACH
Fluency in English, Portuguese and Spanish allows me to perform clinical research activities all over the Americas.
Hello, nice to meet you!
I support companies deliver quality clinical trials
I am a senior-level clinical research professional with over 18 years of experience in clinical trials. Professional experience includes 11 years acting in varied roles, such as Global and Regional Project Manager, Enrollment Manager, Quality Manager, Oversight Monitor, Global Trainer and Clinical Operations Manager (Line/People Manager) and 7 years as CRA.
Significant experience working in Rheumatology, Ophthalmology, Infectious Diseases, Cardiology, Diabetes, Oncology, Hepatology, Neurology, Vaccines, Gastroenterology, in large global/multi-national studies (phases I, II, III, IIIb and IV, including device trials).
Strong program and project management professional with an internationally recognized PMP – PMI certification and a Certificate in Project Management from University of California, Berkeley. Expertise in managing trials globally, remotely from Brazil, covering different regions – Americas, EU and APAC.
1
Years of
Experience
Experience
1
+
Happy Clients
1
cLINICAL tRIALS
1
%
Satisfaction
1
%
Support
Recommendations
Hear out what my clients and colleagues say about me
"Isabel is a rare find. She projects amazingly positive energy and is able to motivate a team behind her even in challenging times. She is a true champion of organizational effectiveness, always looking for the right solution to complex problems, overcoming many obstacles, including resourcing and project timeline constraints. Isabel is not only knowledgeable in ICH-GCP and current on the clinical research trends, but also an individual with great communication and people skills, that would be an asset to any organization. I thoroughly enjoyed working with Isabel in a global clinical leadership capacity. I highly recommend Isabel for any clinical research positions that require a strong and knowledgeable leader."
Ivan Herman
Assoc Clin Lead Director - IQVIA (Canada)
"I worked with Isabel on a programme of complicated studies and she was instrumental in setting up well thought out processes, and in leading the teams to deliver accordingly. She is passionate about effectiveness be delivery of training and is an expert at this. I would love to work with Isabel again, and recommend her wholeheartedly".
Rosie Whittaker
Sr. Director Business Information - PPD (UK)
"Multitasking, great planner and excellant team trainer, very focused on delivery the services in right time with high standard quality. In the studies we worked togheter she planned eveything so carefully that even the most relevant issues experienced in "everyday clinical trials life" were passed without consequences. I am pleased to have worked with her in the past and I would be very happy to have that chance again in the future."
Luisa Rigon
Clinical Research Director - CROMSOURCE (Italy)
"Isabel is a brilliant professional, with remarkable experience in project management and excellence in people's management, decision making and risk analysis. She has experience across many different areas of clinical research, as monitoring, line management, quality management, regional and global training and clinical management in a global scope. Isabel is also distinguished by her intelligence, fast thinking and engagement. She is really a unique professional who is passionate about learning and innovation, and is able to easily translate it to her teams, moving many others to deliver above expectations".
Lucienne Zaneti
Director, Clinical Leads - IQVIA (Brazil)
"Isabel is a very pro active professional, ethic, knowledgeable in project management and clinical research! I have worked with her and can assure she can add value to any team, with global experience."
Renata Bendit
Head Quality Medicine - Boehringer Ingelheim (Brazil)
How it works?
Simple Steps to Success
It all starts with a single first step
Define your needs
List the activites you need help with, your goals and timeline for completion
1
Contact me
In this initial contact we will discuss your needs and I will raise questions to better understand the scope of the work
2
Proposal
Based on the initial conversation, I will prepare a trial-specific services proposal
3
Contract
Upon approval of the proposal, the contracts will be prepared and signed
4
Delivery
After contract execution the work begins. Initial steps usually involve providing access to systems, training and defining client's point of contact for each trial/service
5