Outsourcing & Clinical Operations
Techtrials has a database of CVs and a network of relationships, with which we can identify the perfect professional for your needs.
Contracts are made according to Local Labor Laws. Some important aspects:
The hired employee may stay “In house” at the company, at his home-office or at our local office;
Quick hiring under the Labor Law conditions, minimizing labor lawsuits;·
Employment benefits compatible with those the contracted company offers to the other employees;
Hiring and resignation within our company; ·
Performance follow-up and substitution of the professional whenever necessary;
Ongoing relationship with the client;
TECHTRIALS HAS NO HISTORY OF CLAIMS!!!
Our professionals are carefully selected, taking into account experience and other characteristics that distinguishes a careful and efficient clinical research associate (CRA). Our monitoring processes are efficient and flexible enough to meet the quality standards required for highly controlled Phase I-III trials for the purpose of international registrations (FDA/EMEA) or less controlled Phase IV trials for the purpose of obtaining data for Health Economics or Market Access.
All regulatory steps of a project need to be addressed jointly between the Regulatory department, the Sponsor, and the Clinical Trials Operations in order to guarantee the best strategy for each project. Careful decisions must be made in order to avoid pending issues with IRBs/IECs, CONEP and ANVISA. Our Regulatory team has extensive experience in this area, including having worked on projects of Regulatory Rescue.
Definition of Clinical Research Strategy for Drug Registration within ANVISA. Definition of Clinical Research Costs and Necessary Steps. Meetings with our Medical Team and ANVISA to validate study for registration.
"The best thing in working with TechTrials is their commitment with the project, flexibility to negotiate and an outstanding delivery……no headaches!!"
Dr Rogerio Acquaroli - Medical Director - Ferring Pharmaceuticals
Techtrials offers to pharmaceutical companies services of Project Management and Monitoring of Bioequivalence studies in both the analytical and clinical phase. Our team has experience in over 80 completed projects, ensuring that your study is conducted and performed with the most appropriate supervision.
“Techtrials is a very customer focused company, really adapting to client’s needs. Always ready to jump into any challenge in terms of finding the right people for the right job and delivering the best result. Always a good experience work with them.”
Karina Souza - Clinical Research Operations Manager - Sanofi
Clinical Project Management
The proper management of clinical research projects allows studies to be led smoothly, meting all applicable deadlines. The use of suitable management tools and conceptual models guarantee the success of the project so that clinical data is obtained according to GCP and ICH guidelines. We have highly skilled professionals with more than 15 years of experience in the development of pharmaceutical products in Brazil and abroad.
“I work with Techtrials since the beginning of its operations in Brazil. Techtrials always been a partner in projects that helped me with flexibility and sense of urgency, without ever compromising the quality and commitment to results. Techtrials is our strategic partner in the region, with which I can count on various activities in research and am confident about their value delivery.”
Dr Camille Rodrigues Silva - Ex Medical Diretor - Zodiac
List of Projects Developed
Cardiology - 80 projects
Oncology - 118 projects
Oftalmology - 21 projects
Gastric - 8 projects
Endocrinology - 66 projects
Nervous System - 14projects
Rheumatology - 21 projects
Genito Urinary- 3 projects
Other - 96 projects
Urology - 4 projects
Infections/Vaccines - 38 projects
Proctology - 6 projects
Respiratory - 20 projects