Thywill

Thywill personnel bring long experience in main Pharma Cos with hands on experience in Latin America region. Our key staff has been working in clinical development in the region for almost 15 years, and has been responsible for assembling and managing some of the main clinical development teams working here.

Thywill devotes to help your programme become a success.

Thywill can offer an outstanding list of referees, from US, Europe and the Latin-American region, available for you upon request.

Thywill Services

Thywill is a full service CRO with consulting services also in R&D human resources and surveys.

Main areas are:

Project management:

• Clinical development plan design
• Protocol, CRF and PIC design
• Center selection
• Logistics
• Database management
• Statistics
• Clinical trial report
• Publication management
• Medical writing
• Monitoring
• Registration

Training:

• Investigators’ meetings
• Investigators GCP training
• Trial coordinators GCP training
• Medical advisors
• Monitors training (basic, intermediate and advanced)
  • Thywill standard modules
  • Sponsors’ tailored

Auditing:

• Data integrity
• Regulatory compliance
• Training, education and preparation for audits and inspections
• CRO´s monitoring trials
• Investigating centers
• Institutional Committees
• Ethics Committees
• Subcontracted clinical chemistry centers
• Subcontracted Rx centers
• IT systems

S.O.S. clinical trials:

• Logistical problems
• Press handling - Press crisis
• Delayed recruitment
• Regulatory problems
• Fraud
• Cooperative Groups handling

Thywill Partners

For laboratory:

• Laboratorio Bioquimica Medica
  • Dr. Mauricio Grosman (Director)

For Data Management:

• Data Management and Biostatistics
  • Dr. Maria del Carmen Iannella (Director)

Thywill Facilities

Thywill's headquarters are located in Buenos Aires, Argentina, where Thywill was started and where the main office is. The personnel responsible for regional overview is located at this office.

Thywill operates with its own personnel /offices in México, Guatemala, Costa Rica, Panama, Colombia, Ecuador, Peru, Chile, Venezuela and Uruguay.

Having its own personnel in all these countries, the vast majority of the Spanish-speaking countries where clinics are currently run or have the adequate setting for being set up are under Thywill's umbrella coverage.

Manager's Background

Maria Fernandez Freire (Director) got her degree as MD at Buenos Aires University, with "cum lauda" diploma. She performed her residency in Internal Medicine at the best referral hospital in Argentina. After that she got a postdegree in Clinical Pharmacology and also in System Programming. She is currently about to finalize her Master in International Relationships.

She started in the Pharmaceutical Industry in 1990 as field monitor. She developed her career at Ciba, then Novartis holding the positions of CRA, medical monitor, and medical advisor first for Argentina, then for the Southern Cone of Latin America and afterwards she was promoted to Regional Medical Director of Novartis Oncology covering the whole Latin American Region.

She was one of the pioneers of the concept of Latin American Region potential, working with countries where R&D had not been previously started. She conducted trials which helped grant the approval of drugs in the US and Europe such as Formoterol (Foradil/Fordilen), Oxcarbacepine (Trileptal) , Zoledronate (Zometa), Letrozole (Femara), Imatinib (Glivec). She supervised the Expanded Access Program of Glivec in the region and was the link to the local and international Spanish speaking media regarding Glivec launching. She brought to the region the concept of networking to Professional Societies to increase awareness and recruitment in clinical trials, and also created a system to bring protocol violations to practically zero.

She has been speaker at National Council of Science and Technology, Mercosur Congress of Hematology, National Congress of Oncology, Brazilian Congress of Oncology and DIA meetings. She has been also author of several abstracts / articles related to drugs in Development. She is a member of ASH, ASCO and DIA.

Mansur Estefanos Azzam ( General Manager), graduated as MD at National University of Cuyo, Argentina. He earned afterwards a PhD in Chemistry and has worked since 20 years now in big Pharma Companies always in the Research and Development Field, the last one in Ciba. As a global Company he was usually part of the Global Development Teams, also taking part the IT and statistics interphase with Clinical which was a the time a hallmark for that Company. He started developing the concept of LatinAmerican region as a whole as early as 1990 , and going into other countries than Argentina starting 1991.

After that he directed local CRO in Argentina , and now he decided to join Thywill. He and his team has undergone FDA inspections successful during his CRO experience and also for the work done in Ciba.

He has given lectures on Clinical Research items at scientific meetings in Argentina and various Latin American countries, besides internal companies meetings. He has supervised clinical development teams and has started from hands - on experience to top management, with success and recognition

He is member of the Drug Information Association (DIA).

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