Clinical Research - Interventional clinical studies (Phase I-IV)

Creative PHS manages a wide variety of clinical trials in all majortherapeutic areas, with particular engagement in oncology/haematology, cardiology, ophthalmology, rheumatology,dermatology, respiratory and CNS. From monitoring a singlecenter as part of a multi-national trial, to acting as thecoordinator of multicenter, regional, pivotal trials, Creative PHShas the expertise and resources for virtually all of your clinical trialrequirements. The integral clinical team of Creative PharmaServices has over 20 years working experience in clinicalresearch. Clinical trial management can encompass entireprogrammes, from strategic design advice to clinical reportproduction, or specific individual tasks, such as CT approvalprocedures, monitoring and close out activities.
 
  • 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

Creative Pharma Services is an ISO certified company

HQ: 286 Kifisias Ave., Halandri 152 32, Athens, Greece
Tel:  +30 210 32 59 350
Fax: +30 210 32 59 380
info@creativephs.com