1,003Clinical Projects across40Countries
Optimapharm is dedicated to helping innovative therapies reach patients, delivering over 1000 global Phase I–IV clinical projects with a strong focus on quality, service, and scientific rigour. We partner closely with small, emerging, and commercial biotech organisations, providing a high level of customer attention, responsiveness, and expert guidance throughout the development lifecycle. By combining deep clinical expertise with a service-driven approach, we help transform promising innovations into therapies that deliver real hope and meaningful outcomes for patients worldwide.
Therapeutic Expertise
Functional Capabilities
Navigating complex global regulatory landscapes with expert strategy and execution.
- Review of existing regulatory documentation
- Regulatory advice – developing a robust regulatory strategy
- Managing Clinical Trial Applications towards Competent Authorities and IRBs/IECs
- Managing Clinical Trial Registers
- Meetings and communications with Competent Authorities and IRBs/IECs
- Advice for the development of IMP label and local adaptations of essential study documents
- Clinical trial regulatory updates to Competent Authorities and IRBs/IECs
- Management of local and international compliance submissions
- Adaptation of trial documentation to local regulations
- Preparation and submission of amendments
Ensuring study integrity and patient safety through rigorous, high-quality monitoring.
- Feasibility assessment & site qualification visits
- Site selection, Initiation, Monitoring & Close-out
- Continuous liaison, training, support and motivation
- Verification of source data, protocol & GCP compliance
- Risk assessment & evaluation of enrolment goals
- Corrective and preventative (CAPA) plans
- Provision of all on-site/remote visit reports
- Support/Hosting to audits or inspections
- Remote Monitoring
- Critical review procedures:
- IMP, other drugs and supplies logistical processes
- Regulatory binders and site files
- Informed consents and consent process
- AEs and SAEs management
- Lab sample and supplies handling
- Data and data collection methods
Proactive medical oversight and safety management to ensure trial integrity and subject well-being.
- Project Safety oversight
- Medical advice to sites/study team
- Therapeutic area training
- SAE narratives review/preparation
- AoSE preparation for SUSARs
- Medical Monitoring Report
- Protocol/Eligibility clarifications
- Participants Eligibility check
- MedDRA/WHODRUG coding check
- Relevant Protocol Deviations review
- Unblinding consultation
- 24/7/365 medical coverage
Regulatory and Ethics
Navigating complex global regulatory landscapes with expert strategy and execution.
Services Included
- Review of existing regulatory documentation
- Regulatory advice – developing a robust regulatory strategy
- Managing Clinical Trial Applications towards Competent Authorities and IRBs/IECs
- Managing Clinical Trial Registers
- Meetings and communications with Competent Authorities and IRBs/IECs
- Advice for the development of IMP label and local adaptations of essential study documents
- Clinical trial regulatory updates to Competent Authorities and IRBs/IECs
- Management of local and international compliance submissions
- Adaptation of trial documentation to local regulations
- Preparation and submission of amendments
Clinical Monitoring
Ensuring study integrity and patient safety through rigorous, high-quality monitoring.
Services Included
- Feasibility assessment & site qualification visits
- Site selection, Initiation, Monitoring & Close-out
- Continuous liaison, training, support and motivation
- Verification of source data, protocol & GCP compliance
- Risk assessment & evaluation of enrolment goals
- Corrective and preventative (CAPA) plans
- Provision of all on-site/remote visit reports
- Support/Hosting to audits or inspections
- Remote Monitoring
- Critical review procedures:
- IMP, other drugs and supplies logistical processes
- Regulatory binders and site files
- Informed consents and consent process
- AEs and SAEs management
- Lab sample and supplies handling
- Data and data collection methods
Medical Monitoring
Proactive medical oversight and safety management to ensure trial integrity and subject well-being.
Services Included
- Project Safety oversight
- Medical advice to sites/study team
- Therapeutic area training
- SAE narratives review/preparation
- AoSE preparation for SUSARs
- Medical Monitoring Report
- Protocol/Eligibility clarifications
- Participants Eligibility check
- MedDRA/WHODRUG coding check
- Relevant Protocol Deviations review
- Unblinding consultation
- 24/7/365 medical coverage
Dedicated leadership to drive your project on time, within budget, and to the highest standards.
- Project planning, scope, tracking and reporting
- Creation of project plans
- Risk management and mitigation strategies
- Facilitating regular project meetings
- Primary point of contact for stakeholders
- Budgetary and schedule management
- Maintaining timely project information flow
- Assessment against KPIs
- Preparation of all status reports
- Vendor management and payments
- Training coordination for all parties
Delivering high-quality, reliable data through comprehensive management solutions.
- Protocol design and data management plan input
- Case Report Form (CRF) design and review
- Database design
- Data entry, validation, analysis and transfer
- Query management
- Serious Adverse Events (SAE) management
- CDISC implementation
- SDTM data consolidation and conversion
- ePRO (Patient diary)
- Central data sourcing (labs, imaging)
- Customised Report Delivery
- Data reconciliations
- Medical Coding (MedDRA & WHO-ATC)
- Flexible Staffing Solutions
Advanced statistical expertise to optimise study design and data interpretation.
- Input in study design
- Development of statistical analysis plan
- Sample size calculation
- Randomisation (envelopes and IXRS)
- Statistical analysis
- Interim analyses
- CDISC & data mapping for FDA submissions
- PK/PD modelling
- Delivery of TFL Reports
- CSR preparation (ICH Part E3)
- Creation of DSMB Charts
- Allocation of statistical profiles for DSMB
- Flexible Staffing Solutions
Project Management
Dedicated leadership to drive your project on time, within budget, and to the highest standards.
Services Included
- Project planning, scope, tracking and reporting
- Creation of project plans
- Risk management and mitigation strategies
- Facilitating regular project meetings
- Primary point of contact for stakeholders
- Budgetary and schedule management
- Maintaining timely project information flow
- Assessment against KPIs
- Preparation of all status reports
- Vendor management and payments
- Training coordination for all parties
Data Management
Delivering high-quality, reliable data through comprehensive management solutions.
Services Included
- Protocol design and data management plan input
- Case Report Form (CRF) design and review
- Database design
- Data entry, validation, analysis and transfer
- Query management
- Serious Adverse Events (SAE) management
- CDISC implementation
- SDTM data consolidation and conversion
- ePRO (Patient diary)
- Central data sourcing (labs, imaging)
- Customised Report Delivery
- Data reconciliations
- Medical Coding (MedDRA & WHO-ATC)
- Flexible Staffing Solutions
Biostatistics
Advanced statistical expertise to optimise study design and data interpretation.
Services Included
- Input in study design
- Development of statistical analysis plan
- Sample size calculation
- Randomisation (envelopes and IXRS)
- Statistical analysis
- Interim analyses
- CDISC & data mapping for FDA submissions
- PK/PD modelling
- Delivery of TFL Reports
- CSR preparation (ICH Part E3)
- Creation of DSMB Charts
- Allocation of statistical profiles for DSMB
- Flexible Staffing Solutions
Clear, compliant, and scientifically accurate documentation for every stage of development.
- Technical
- Clinical study protocols (creation/review)
- Synopses
- Investigator brochures
- IMPD Dossiers
- Clinical study report (CSR)
- Scientific
- Abstracts, posters & presentations
- Manuscripts for Journals
- Literature search and reviews
- Others
- Product monographs
- Patient education materials
- Informed consents and assents
- Medical Consultancy and Support
- Study design and strategy support
- Expert physician allocation
- Protocol technical review
- IB or IMPD medical review
Comprehensive safety surveillance and risk management to protect patients and products.
- Safety Management Plans (SMPs) creation
- Tailored safety database & forms
- Safety data entry
- ICSR management & narratives
- Medical assessment
- Expedited & periodic safety reporting
- EMA EudraVigilance registration
- Reporting to DMC / Sponsor
- Reconciliation of SAEs
- Risk/benefit assessment
- Safety data review per patient
- 24h Safety vigilance availability
- Training
Medical Writing
Clear, compliant, and scientifically accurate documentation for every stage of development.
Services Included
- Technical
- Clinical study protocols (creation/review)
- Synopses
- Investigator brochures
- IMPD Dossiers
- Clinical study report (CSR)
- Scientific
- Abstracts, posters & presentations
- Manuscripts for Journals
- Literature search and reviews
- Others
- Product monographs
- Patient education materials
- Informed consents and assents
- Medical Consultancy and Support
- Study design and strategy support
- Expert physician allocation
- Protocol technical review
- IB or IMPD medical review
Pharmacovigilance
Comprehensive safety surveillance and risk management to protect patients and products.
Services Included
- Safety Management Plans (SMPs) creation
- Tailored safety database & forms
- Safety data entry
- ICSR management & narratives
- Medical assessment
- Expedited & periodic safety reporting
- EMA EudraVigilance registration
- Reporting to DMC / Sponsor
- Reconciliation of SAEs
- Risk/benefit assessment
- Safety data review per patient
- 24h Safety vigilance availability
- Training