Services

Regulatory & Ethics

With country based regulatory specialists and experienced Country Managers, OPTIMAPHARM is delivering high experience to clients around the world, achieving highly competitive start up timelines whist accessing some of most dynamic recruitment regions in Europe.

Regulatory & Ethics services

• • Regulatory advice – developing Local/Regional Regulatory strategy
• • Review and update of existing Regulatory documentation
• • Obtaining Regulatory approvals aswell 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 pediatric clinical trials/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.

Monitoring Services

OPTIMAPHARM is proud of having monitors with university degrees, predominantly in medical and life sciences. On average, our CRAs have more than 5 years of experience in monitoring.

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)

Monitoring services

• • 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

• • Site Contracts and Budget development and negotiation
• • Routine Site communication
• • Newsletters
• • Grants Administration

Project Management

OPTIMAPHARM has certified Project Managers with experience in managing cross functional teams, ensuring that trials KPI and milestones are met in agreed timelines. Having an average of 108% of recruitment target achieved we can guarantee success with our “know-how”.

Project management services

• • Project planning, tracking and reporting
• • Overall project supervision
• • Regular project meetings/teleconferences in order to review/plan the project scope, assumptions, timelines and activities
• • Primary contact with client/sites/vendors
• • Timelines and budget management
• • Maintenance of the project information flow in a timely and proactive manner
• • Preparation of weekly/monthly/quarterly status reports
• • Vendor Management and Payments

Data Management

OPTIMAPHARM has partnered with some of the industry leaders in this area, thus providing its 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
• • Database release

biostatistics

Services we provide

• • 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

Medical Writing

Services we provide

• • Clinical development plan
• • Clinical trial design
• • Clinical study protocols
• • Investigator's Brochure
• • IMPD
• • Informed Consents, Patient Information Sheets, Assents
• • Publications and abstracts
• • Literature review and proof reading

safety & Pharmacovigilance

Services we provide

• • Safety Data Entry
• • Medical Assessment
• • Eudravigilance Reporting/Authorities in EU
• • Reporting to DMC/Sponsor as applicable
• • Signal detection
• • Hosting of safety database
• • Safety Surveillance for clinical and medical device studies
• • Safety report writing, e.g. DSURs/annual safety reports/PSURs
• • Risk-management plan