Creative Pharma Services
What we do
- Feasibilities
- Site Screening & Selection
- Site relationship development & continuity
- Organization of Investigators Meetings
- Regulatory & IRB Submissions & FU reporting
- Contracts negotiations, preparation & full execution
- Budget development & overview
- Study Files' Preparation, Maintenance, Close out
- Trial support services (Project Logistics)
- On-site Monitoring visits (pre-study, initiation, interim & close out visits)
- Quality visits & pre-audit prep
- Post Audit CAPA implementation
- Co-Monitoring visits
- On-site coordination
- Project Management & Clinical Team Coordination
- The main contact liaison between Creative Clinical Team & Pharmaceutical Company
- Ensure delivery of set project specific KPIs as agreed with Pharmaceutical Company (at Project level)
- Ensure achievement of key project specific milestones
- Perform co-monitoring visits as agreed upon with Pharmaceutical Company (at project level/according to Global Study Monitoring Plan, ICH/GCP guidelines)
- Follow-up on training requirements of the clinical team (CRAs, CTAs)
- Develop Risk Management & Mitigation Plans
- Post Marketing Surveillance Studies
- Post Authorization Safety Studies-PASS
- Epidemiological Studies
- Observation Studies
- Pharmacoeconomic Studies
- ISS studies
Services:
- Feasibilities
- Site Screening & Selection
- Site relationship development & continuity
- Organization of Investigators Meetings
- Regulatory & IRB Submissions & FU reporting
- Contracts negotiations, preparation & full execution
- Study Files Preparation, Maintenance, Close out
- On-site and Remote Monitoring visits (pre-study, initiation, interim & close out visits)
- Co-Monitoring visits
- On-site coordination
- Data management (query generation & resolution)
- Project Management & Clinical Team Coordination
- The main contact liaison between Creative Clinical Team & Pharmaceutical Company
- Ensure delivery of set project specific KPIs as agreed upon with Pharmaceutical Company
- Ensure achievement of key project specific milestones
- Perform co-monitoring visits as agreed upon with Pharmaceutical Company (at project level/according to Global Study Monitoring Plan, ICH/GCP guidelines)
- Follow-up on trainings requirements of the clinical team (CRAs, CTAs)
- Develop Risk Management & Mitigation Plans
- Medical Writing- Interventional & Non-Interventional Clinical Studies
- Protocol development
- ICF development
- CRF development
- Medical advise
- Medical Translation
- Clinical Study & Safety Reporting
- Preparation of new marketing authorization applications for medicinal products and submission to Health Authorities
- Preparation of variations of medicinal products and submissions to Health Authorities
- Preparation of renewals of medicinal products and submissions to Health Authorities
- Translation of SmPCs, PIL, Labelling
- Preparation and submission of new medical device information to Health Authorities
- Preparation and submission of product information for cosmetics and health supplements to Health Authorities
- Advice and guidance on registration procedures
- Review and evaluation of product data before submission to Health Authorities
- Dossier preparation and Scientific writing
- Pre- and Post- marketing regulatory support
- PV Consultancy & Project Management
- Serious Adverse Event Case Processing of Initial/Follow-up reports
- Individual Case Safety Report (ICSR) Processing of Initial/Follow-up reports
- Adverse Device Effect (ADE) / Medical Device Incident (MDI) Case Processing, coding & follow-up
- MedDRA coding
- Case Narratives
- Medical Monitoring
- Pharmacovigilance Physician services
- Global Expedited Case Reporting
- EudraVigilance reporting using EVWEB
- Responsible Person for EudraVigilance
- Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) entry & maintenance
- SafetyData Management & Global Safety Database – Oracle Argus
- Legacy case transfer
- Signal Detection & Evaluation
- Development Safety Update Report (DSUR) preparation & submission
- Global & Local Literature Search & Review in support of the DSUR
- Periodic Safety Update Report (PSUR) preparation & submission
- EU Qualified Person for Pharmacovigilance (QPPV) & deputy
- Device Vigilance Report Preparation & Submission
- Pharmacovigilance Quality Assurance including SOP development
- Monthly compliance & status reporting
- Reconciliation of Serious Adverse Events
- Risk Management
- Study documentation review & update, including protocol & Investigator's Brochure
- Periodic reporting
- CRA
- ICH GCP guidelines and Country Legislation
- Clinical Reporting
- Safety reporting
- Efficient / Effective SDV
- Inspection Readiness
- Audit Preparation
- Risk based monitoring
- HR for Pharmaceutical companies
- Medical
- protocol
- Therapeutic Areas training
- Creative Pharma Services provide its clients, high caliber, bespoke customer services with qualified team
- The success of a customer support center service lies mostly on the people who man it. We always start by choosing the right candidates, people with natural empathy and communication skills. We guarantee this process through careful screening and with the aid of bespoke tests.
- The employees that undertake this demanding project have excellence knowledge of call handling and exhibit a customer-centric behavior in all their communications.
- To ensure the above, all staff trained in the fundamentals of customer service, communication skills, and the customer experience journey, beforehand. All training is bespoke and takes into consideration, apart from the aforementioned generic topics, your internal culture and unique client service approach
- An assessment of the number of staff required
- To ensure that the service will remain uninterrupted for the duration of the project, CPhS retain on-call a fully trained backup agent at all times
- Call recording for quality measurement or compliance can be setup according to client's specifications.
We can provide Scientific Personnel to cover positions such as: CTA, CRA, Pharmacovigilance, Regulatory, Medical, Project Manager, CTC (Clinical Team Coordinator), Site Coordinator, Sales Manager, Sales Specialists etc.
HQ: 286 Kifisias Ave., Halandri 152 32