Our Solutions

Our Solutions

Planning

Execution

  • Study Design and Planning
  • Regulatory Affairs and Submissions
  • Patient Recruitment
  • Quality Assurance and Compliance

Study Design and Planning

  • Compliance and risk management oversight
  • Clinical trial protocol development
  • Statistical consulting
  • Sample size estimation
  • Clinical trial feasibility assessment
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Regulatory Affairs and Submissions

  • Regulatory consulting and strategy
  • IND and CTA submissions to the RA
  • Ethics committee/IRB submissions
  • Regulatory submissions to MOH
  • Regulatory document management

Patient Recruitment

  • Protocol review
  • Recruitment strategies: Round tables, media campaigns, patient referrals, email blast, etc.
  • Clinical Trials Educators/Clinical Team Lead visits (MD Staff) services.
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Quality Assurance and Compliance

  • GCP audits
  • Preparation for Regulatory Inspections
  • Implementation of Quality management Systems
  • Risk management planning and assessment

Study Design and Planning

  • Compliance and risk management oversight
  • Clinical trial protocol development
  • Statistical consulting
  • Sample size estimation
  • Clinical trial feasibility assessment
https://sayanibpo.com/wp-content/uploads/2024/05/s10-2.png

Regulatory Affairs and Submissions

  • Regulatory consulting and strategy
  • IND and CTA submissions to the RA
  • Ethics committee/IRB submissions
  • Regulatory submissions to MOH
  • Regulatory document management
https://sayanibpo.com/wp-content/uploads/2024/05/s2-1.png

Patient Recruitment

  • Protocol review
  • Recruitment strategies: Round tables, media campaigns, patient referrals, email blast, etc.
  • Clinical Trials Educators/Clinical Team Lead visits (MD Staff) services.
https://sayanibpo.com/wp-content/uploads/2024/05/s3-1.png

Quality Assurance and Compliance

  • GCP audits
  • Preparation for Regulatory Inspections
  • Implementation of Quality management Systems
  • Risk management planning and assessment
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  • Clinical Operations and Site Management
  • Medical Writing and Documentation
  • Pharmacovigilance and Safety
  • Site training and support

Clinical Operations and Site Management

  • Project management and oversight
  • Clinical monitoring
  • Site Management
  • Investigator meeting organization
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Medical Writing and Documentation

  • Clinical trial protocol and Investigational Brochure development
  • ICF Preparation
  • Clinical Study Report Preparation
  • Scientific article writing & publishing strategies
  • Bibliographic reviews
  • Scientific presentations creation
  • Poster preparation
  • Medical translations

Pharmacovigilance and Safety

  • Adverse event reporting and management
  • Safety and medical monitoring, pharmacovigilance activities
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Site training and support

  • GCP training
  • SOP preparation
  • Study coordinator resourcing

Clinical Operations and Site Management

  • Project management and oversight
  • Clinical monitoring
  • Site Management
  • Investigator meeting organization
https://sayanibpo.com/wp-content/uploads/2024/05/cro1.png

Medical Writing and Documentation

  • Clinical trial protocol and Investigational Brochure development
  • ICF Preparation
  • Clinical Study Report Preparation
  • Scientific article writing & publishing strategies
  • Bibliographic reviews
  • Scientific presentations creation
  • Poster preparation
  • Medical translations
https://sayanibpo.com/wp-content/uploads/2024/05/s6-3.png

Pharmacovigilance and Safety

  • Adverse event reporting and management
  • Safety and medical monitoring, pharmacovigilance activities
https://sayanibpo.com/wp-content/uploads/2024/05/s7-1.png

Site training and support

  • GCP training
  • SOP preparation
  • Study coordinator resourcing
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  • Clinical Supplies
  • Late phase studies
  • Functional Service Provider

Clinical Supplies

  • Depot for Investigational Product and other study supplies
  • Import and export support
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Late phase studies

  • Real World Evidence
  • Observational studies
  • Pharma Economic Studies

Functional Service Provider

  • Expert Integration into Work Teams
  • Assignment of Specific Resources and Roles: CRAs, CTA, Regulatory staff, Project Manager, Clinical Leads
  • Implementation of Tailored Processes and Procedures
  • Results Monitoring and Goal Achievement Supervision
https://sayanibpo.com/wp-content/uploads/2024/05/s4-3-300x300.png

Clinical Supplies

  • Depot for Investigational Product and other study supplies
  • Import and export support
https://sayanibpo.com/wp-content/uploads/2024/05/s9.png

Late phase studies

  • Real World Evidence
  • Observational studies
  • Pharma Economic Studies
https://sayanibpo.com/wp-content/uploads/2024/05/s10-1.png

Functional Service Provider

  • Expert Integration into Work Teams
  • Assignment of Specific Resources and Roles: CRAs, CTA, Regulatory staff, Project Manager, Clinical Leads
  • Implementation of Tailored Processes and Procedures
  • Results Monitoring and Goal Achievement Supervision
https://sayanibpo.com/wp-content/uploads/2024/05/s4-3.png

Therapeutic Areas

Oncología
Cardiología
Neurología
Enfermedades infecciosas
Vacunas
Endocrinología
Gastroenterología
Reumatología
Dermatología
Psiquiatría
Enfermedades autoinmunes
Medicina genética
Obstetricia y ginecología
Pediatría
Urología
Oftalmología
Otorrinolaringología
Enfermedades respiratorias

Study phases

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Phase I


Evaluation of safety and dosage in a small group of healthy volunteers or patients.
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Phase II


Evaluation of efficacy and side effects in a larger group of patients with the target disease
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Phase III


Evaluation of efficacy, safety, and comparison with standard treatments in a larger population of patients.
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Phase IV


Post-market studies to monitor the long-term safety and effectiveness of the medication in real-world conditions of use.
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