With country based regulatory specialists and experienced Country Managers, OPTIMAPHARM’s regulatory team understand the nuances and complexities of each country’s regulatory demands
and processes, therefore extremely capable to expedite the start-up of clinical projects across Europe whilst accessing some of most dynamic recruitment regions in Europe.
Regulatory & Ethics services
• Regulatory advice – developing a robust Local/Regional Regulatory strategy
• Review and updating of existing Regulatory documentation
• Obtaining Regulatory approvals as well as Local/Central Ethic Committee approvals
• Meetings and interactions with CentralLlocal Ethic Committees and Regulatory Agencies
• Expertise in Ethics and Regulatory submission of the CTA for paediatric clinical trials and psychiatric clinical trials
• Advice in the development of IP label and local adaptations of essential study documents
• Post-approval Regulatory updates to Ethics Committees and Regulatory Authorities.
The CRA is the client’s contact with site and we cherish that relationship within OPTIMAPHARM that.
OPTIMAPHARM is proud to have monitors with university degrees, predominantly in medical and life sciences. On average, our CRAs have more than 5 years of experience in monitoring and adopt a pragmatic, yet disciplined approach at sites to truly support the Investigators and nursing teams.
Monitoring and site visits
• Site Selection / Pre-Study Visits
• Site Initiation Visits
• Interim Site Monitoring Visits (blinded,unblinded, on-site and remote monitoring)
• Site Close Out Visits
• Senior Management and Site Motivational Visits (as required)
• Source Data Verification (SDV)
• Protocol, regulatory and ICH GCP compliance verification
• Review of study Investigational Medicinal Product and other study drugs or supplies(storage, receipt records, supplies, drug dispensing and return records, subject compliance)
• Review of Regulatory Binders/Site Files
• Review of Informed Consents and Consent process
• Review of AEs and SAEs and ensuring subject safety
• Review of laboratory sample handling/reporting procedures and supplies
• Continuous and close liaison with Investigators and other Site personnel
• Providing the Site personnel with relevant new study information and training
• Critical review of data and data collection methods
• Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• Evaluation of enrolment goals and troubleshooting site performance
• Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow-up of each, individual CAPA until timely resolution
• Preparation of Monitoring and other on-site/remote visit reports
Site management services
It’s all about the safety of patients and we, at OPTIMAPHARM take a patient-centric approach to our trials, thereby facilitating recruitment and reducing the number of withdrawals, whilst ensuring our sponsors requirements are fully met.
• Site Contracts and Budget development and negotiation
• Routine Site communication
• Grants Administration
The high-quality supervision of a project is amongst the most important factors in delivering success.
OPTIMAPHARM has certified Project Managers with experience in managing cross functional teams, ensuring that trials Key Performance Indicators (KPIs) and milestones are met. With an average recruitment rate of 108% of recruitment target, we can guarantee success with our “know-how”.
Project management services
• Project planning, tracking and reporting
• Pro-active development of project-focused risk and mitigation strategies
• Overall project supervision
• Regular project meetings/teleconferences to review/plan the project scope, assumptions, timelines and activities
• Primary contact with client/sites/vendors
• Focused timelines and budget management
• Maintenance of the project information flow in a timely and proactive manner
• Preparation of weekly/monthly/quarterly status reports
• Project performance measurement and management against agreed Key Performance Indicators
• Vendor Management and Payments
Data management is a key element of any clinical trial, especially with the new
GDPR guidelines that governs how data must be managed across the whole of
Europe. Appropriate data management is critical in providing valuable and
solid data to Regulators.
OPTIMAPHARM has partnered with some of the industry leaders in this area, thus providing our clients with best available services and tailor made approach.
Data management services
• Input on Protocol design
• Case Report Form (CRF) design & review
• Database design
• Data entry
• Data validation/verification
• Data transfer
• Query process
• Medical term coding
• Quality management procedures
• Data analysis
• SDTM data package
• Database release
Statistics play a crucial role in clinical trials and in the drug development
process, from trial design to protocol development. Having a fundamental
understanding of statistical issues can uphold the integrity of a clinical trial
and improve communication between clinicians and statisticians. Through our
partnering network we can provide access to some of the leading experts in
Through our partnering network we can provide access to some of the leading experts in biostatistics.
• Input in study design, sample size/statistical power determination, analysis plan and preparation of statistical reports
• Statistical analysis
• Interim analyses and meta analyses
• CSR preparation as per ICH Part E3
The success of Medical writing in clinical research depends upon the proper
documentation and the exactness of the research, its planning and results.
OPTIMAPHARM offers flexible solutions, working with experienced medical writers in various therapeutic areas.