- 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
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.
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
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.
Quality Assurance and Compliance
- GCP audits
- Preparation for Regulatory Inspections
- Implementation of Quality management Systems
- Risk management planning and assessment
- 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
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
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
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
Site training and support
- GCP training
- SOP preparation
- Study coordinator resourcing
- Clinical Supplies
- Late phase studies
- Functional Service Provider
Clinical Supplies
- Depot for Investigational Product and other study supplies
- Import and export support
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
Clinical Supplies
- Depot for Investigational Product and other study supplies
- Import and export support
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
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
Phase I
Evaluation of safety and dosage in a small group of healthy volunteers or patients.
Phase II
Evaluation of efficacy and side effects in a larger group of patients with the target disease
Phase III
Evaluation of efficacy, safety, and comparison with standard treatments in a larger population of patients.
Phase IV
Post-market studies to monitor the long-term safety and effectiveness of the medication in real-world conditions of use.