CRO - Synvia
Fale Conosco
Fale Conosco
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Your full-service
CRO in Brazil

Synvia CRO

Synvia CRO is a Contract Research Organization with over 20 years of experience and more than 200 satisfied pharmaceutical clients around the world.

  • We offer a comprehensive range of services, from phase I to IV clinical trials in a full-service model to specialized support in regulatory, scientific, and clinical operations.
  • Our modular approach provides customized solutions for specific needs always committed to offer quality and excellence to our clients. 
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The best solutions for your projects

We customize our services to your needs, being able to provide solutions to specific outsourcing activities, from regulatory strategies to statistical analysis.

Project Management

Driving Clinical Excellence through Strategic Problem-Solving

With a robust problem-solving mindset, our strong, communicative, and detail-oriented project team ensures that clinical trial deliverables are met on time.

  • Compliance: Ensure that protocols, plans, and projects are implemented and executed in accordance with guidelines, legislation, and Standard Operating Procedures (SOPs).
  • Project Management: Plan, initiate and manage clinical projects. Oversee clinical trial progress against the project management plan and execute quality indicators and targets (KPIs).
  • Risk Assessment and Mitigation: Identify risks and develop and implement mitigation plans in collaboration with team members and other stakeholders.
  • Communication: Serve as the primary point of contact for the sponsor and project team members on a day-to-day basis
  • Tools and Documents: Develop study-specific documents and maintain Trial Master Files (TMF) and Electronic Trial Master Files (eTMF).
  • Resource management: Ensure staff are adequately trained and that equipment and tools are available to perform required tasks.
  • Reporting: Provide progress reports to the internal project team and stakeholders, keeping all parties informed.
  • Contract negotiation: Negotiate contracts with research sites, suppliers, and vendors and manage logistics efficiently.
  • Financial control: Manage project finances following the sponsor’s contract and budget, ensuring fiscal responsibility.
  • Compliance: Ensure that protocols, plans, and projects are implemented and executed in accordance with guidelines, legislation, and Standard Operating Procedures (SOPs).
  • Project Management: Plan, initiate and manage clinical projects. Oversee clinical trial progress against the project management plan and execute quality indicators and targets (KPIs).
  • Risk Assessment and Mitigation: Identify risks and develop and implement mitigation plans in collaboration with team members and other stakeholders.
  • Communication: Serve as the primary point of contact for the sponsor and project team members on a day-to-day basis
  • Tools and Documents: Develop study-specific documents and maintain Trial Master Files (TMF) and Electronic Trial Master Files (eTMF).
  • Resource management: Ensure staff are adequately trained and that equipment and tools are available to perform required tasks.
  • Reporting: Provide progress reports to the internal project team and stakeholders, keeping all parties informed.
  • Contract negotiation: Negotiate contracts with research sites, suppliers, and vendors and manage logistics efficiently.
  • Financial control: Manage project finances following the sponsor’s contract and budget, ensuring fiscal responsibility.
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Clinical Monitoring

Data quality and integrity

Our highly qualified monitoring team, certified in advanced tools, ensures the integrity and quality of data collected during the study. 

  • Site identification, qualification, and selection
  • Regulatory document preparation and collection
  • General contract negotiation
  • Investigator meeting planning and presentation
  • Handling of SAE & Closeout visits
  • Site personnel training
  • Remote and on-site monitoring
  • Investigational product and materials accountability
  • Site identification, qualification, and selection
  • Regulatory document preparation and collection
  • General contract negotiation
  • Investigator meeting planning and presentation
  • Handling of SAE & Closeout visits
  • Site personnel training
  • Remote and on-site monitoring
  • Investigational product and materials accountability
Contact Us
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Regulation Affairs

Technical-regulatory alignment

Our highly experienced team will find the best regulatory strategy for your product, identifying the appropriate pathway within the current local environment and the leading regulatory authorities.

  • Regulatory strategies
  • Agency interactions
  • Regulatory feasibility
  • Gap analysis/ Due diligence
  • Elaboration of dossiers
  • Regulatory lifecycle management
  • Regulatory strategies
  • Agency interactions
  • Regulatory feasibility
  • Gap analysis/ Due diligence
  • Elaboration of dossiers
  • Regulatory lifecycle management
Contact Us
regulation-affairs

Medical Writing

Scientific documents of different types

Our team of medical writers is ready to assist your company in preparing scientific documents, including regulatory and research-related materials. With expertise in science, research, and current guidelines, we ensure the information is presented at the right level for your needs.

  • Clinical study protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Investigator’s brochure
  • Patient questionnaire
  • Scientific publications
  • Safety and efficacy reports/rationale
  • Clinical study protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Investigator’s brochure
  • Patient questionnaire
  • Scientific publications
  • Safety and efficacy reports/rationale
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Biostatistics

One of the main pillars of scientific research

Biostatistics has become increasingly important and relevant in recent years. Our team of specialists is ready to meet your needs, providing comprehensive support at every stage.

  • Endpoint development for study design in cooperation with medical writing teams
  • Sample size calculations and randomization schemes
  • Statistical analysis
  • Statistical Analysis Plan (SAP) development
  • Technical meetings with regulatory agencies
  • Endpoint development for study design in cooperation with medical writing teams
  • Sample size calculations and randomization schemes
  • Statistical analysis
  • Statistical Analysis Plan (SAP) development
  • Technical meetings with regulatory agencies
Contact Us
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Central Laboratory

High-complexity diagnostic analysis

Analytical support for clinical trials, offering a range of solutions from targeted to full-service, with a focus on customization and development.

  • Manufacturing and distribution of laboratory kits
  • Management of the entire logistics chain, prioritizing the safety, speed, and integrity of the samples
  • Over 4,000 tests in our portfolio
  • 100,000+ samples processed per month
  • 30+ LC-MS/MS systems
  • Manufacturing and distribution of laboratory kits
  • Management of the entire logistics chain, prioritizing the safety, speed, and integrity of the samples
  • Over 4,000 tests in our portfolio
  • 100,000+ samples processed per month
  • 30+ LC-MS/MS systems
Contact Us
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Why Conduct Clinical Trials in Brazil?

Brazil offers a diverse population of 220 million, a high-quality network of hospitals, and a well-respected regulatory agency, ANVISA.

The Brazilian pharmaceutical market is one of the largest in the world and maintains robust annual growth.

  • Synvia CRO supports companies that want to access this Market as well as companies that are just looking for the most cost-effective alternative for clinical trials worldwide.
  • Our international reach and local expertise ensure seamless and effective solutions for our sponsors.
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Logistical and regulatory management

We provide comprehensive support for the importation of
controlled and non-controlled materials in clinical trials.

We handle every step — from currency exchange and
SWIFT processing to final reporting — all to provide the
most cost-effective solutions for our clients.

  • Coordination of transport, flights, and material storage
  • Issuance of authorizations and reporting to ANVISA and the Federal Revenue Service 
  • Cost analysis and negotiation for better pricing

State-of-the-art services

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Personalized Experience

We provide the personalized and
boutique service you would expect
from a smaller CRO while being backed
by a large, consolidated group.

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Competitive Pricing

Our extensive knowledge of the clinical
trials landscape in Brazil enables us to
deliver top-quality services at
competitive prices.

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End-to-End Solutions

Streamline your operations by
outsourcing all your needs to a single
company, ensuring seamless and
effective integration with one point
of contact.

Contact us

If you’re interested in becoming a partner, please fill out the form.

Endereço

  • Rua Mário Giordano, 146
    Jardim América, Paulínia - SP
    13140-614
  • CNPJ: 07.339.867/0001-15

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