Recently, our own Karina De Lazzari, Vice President, Latin America Clinical Operations, based in Buenos Aires, Argentina, was elected as president of CAOIC (Cámara Argentina de Organizaciones de Investigación Clínica), or Argentine Chamber of Clinical Research Organizations.
CAOIC was founded in September 2006 by a group of CROs as a non-profit organization whose mission is to bring together and represent CROs operating in Argentina and international markets.
As the only woman leading a CRO chamber within Latin America, Karina shares her thoughts on this achievement and her plans for advancing the organization during her two-year term as president.
How did you get involved in CAOIC?
During last few years, I have had the opportunity to participate in all CAOIC meetings with stakeholders and global and local customers and contribute to initiatives such as informed consent training provided in partnership with the local Ministry of Health and Ethics Committee. Two years ago, I was appointed as vice president and worked to develop clinical monitoring training with the collaboration of an ethics committee and local university to increase qualified talent within the local market.
What does the appointment as president mean to you?
I am so honored to lead CAOIC, because we are a driving force behind increasing the quality and ethical standards for clinical research within Argentina. I am grateful to my CAOIC colleagues who supported my appointment.
What do you hope to accomplish during your term?
I look forward to building upon the success of our current CAOIC initiatives and developing new initiatives during the next two years.
In 2019, we worked with all local stakeholders to achieve shorter approval timelines and increase the number of clinical studies by 70%. Overall timelines have decreased by 41%, with a median of 52 working days for the studies submitted as of December 2018. The data also show a significant reduction in timeliness when comparing submissions done per semester in 2017 and 2018.
Looking forward, I would like to promote the importance and scope of clinical research activity as I represent the CRO industry with public regulatory bodies and authorities and private institutions of the country and abroad.
In addition, I plan to promote training and continuing education and encourage communication among our members and partners. I will offer advice and assistance to our associates and third parties, in compliance with international professional and ethical standards in the conduct of clinical research, and develop and promote methods and procedures that ensure compliance with them.
Finally, I will work to preserve the rights of patients and healthy volunteers participating in clinical trials in Argentina, in line with the Clinical Good Practice Standards and local regulations.
How did your work at Syneos Health prepare you to represent the CAOIC organization?
I feel well-prepared to take on the important challenge of heading CAOIC, thanks to my line manager’s support and encouragement to develop my career and expand my experience and knowledge across the clinical research environment at Syneos Health. Being part of the company’s Clinical Monitoring and Training initiatives during the last 15 years has given me broad exposure to different therapeutic areas, types of studies and business units. In addition, I have had the opportunity to manage the business with larger Pharma customers, as well as interact with most customers in the country.
What are the opportunities for doing clinical research in Argentina?
There are a number of compelling reasons for biopharmaceutical companies to conduct clinical research in Argentina:
- Presence of good healthcare infrastructure and facilities: all of Argentina’s provinces have an organized network of hospital and outpatients services.
- Centralized study subject population: the urban population in Argentina has close proximity to investigative sites, close patient-physician relationships, a presence of still treatment-naïve population, and the prevalence of certain diseases that drives high participation rates.
- Experienced research investigators: Argentina’s medical community has been actively involved in clinical research for a number of years.
- Shorter approval timelines increases country predictability: changes in regulations and processes are driving efficiencies, and time-to-initiate investigative sites is now competitive at a global level.
Learn more about how we are shortening the distance from lab to life® in Latin America and around the globe at www.syneoshealth.com.
Phone: +1 919 876 9300
Fax: +1 919 876 9360
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