Clinical Operations

Clinical Trials Monitoring

 

We provides field monitoring, site  management  and administration services in Poland.

Routine monitoring is performed accordingly to ICH GCP rules, FDA guidelines and local regulatory requirements.

 

Monitoring activities include:

  • Site staff training

  • CRF review

  • Source Data Verification (100%)

  • Protocol compliance control

  • Regulatory requirements compliance control

  • Drug inventory and accountability

  • Safety review

  • Documentation maintenance and update

  • Remote monitoring in EDC studies

  • Regular contacts with sites between on site visits
     

Our CRAs are professionals with life sciences, medical or pharmaceutical background. They are located in strategic cities of the country.

All CRAs undergo regular intensive training designed exclusively for their individual needs, and experience. Clinical Development   Training Programs are prepared in cooperation with training specialized providers.

 

Project Management

 

Our experienced Project Managers coordinate all activities related to the study, manage study timelines and budget and maintain close communication with sponsor, project team and sites.

Project Management group works on keeping each project on time and within planned budget.

Each Project Team is motivated and integrated, with local expertise and therapeutic experience and knowledge.

Clinical Development provides study tracking of each project and timely monitoring of data and communicates study status to sponsor on regular basis.

PMS Studies

 

Post-Marketing safety surveillance studies are used to monitor the safety of marketed medicines.

Post Marketing Surveillance (PMS) study is usually designed as a prospective cohort study. Its main objective is to gather more safety data about new drug. PMS study can be use control group with comparator or be uncontrolled.

Clinical Consulting provides you with full service in PMS studies, from study planning and design to final report:

  • Planning and setup of study plan, simplified protocol and abbreviated CRF

  • Sites selection

  • Project management

  • Data entry and validation

  • Statistical analysis and reporting
     

The benefits for your company of PMS study conducted by Clinical Development are as follows:

  • More data about safety profile of your product

  • Increased awareness of your company product in medical practice

  • Publications of study results in widely recognized journals
     

Rescue Studies

Clinical Development takes over clinical trials in all phases, that could not meet planned timelines due to:

  • poor recruiment

  • incorrect project management and monitoring

  • bancruptcy of CRO

  • other reasons

Feasibility Studies

 

Our Clinical Trials Network Inventory makes us the fastest responders to a feasibility request for a project. Clinical Consulting has created and now maintains and continuously expands its own database of Investigators all over the country, each one being a prominent figure in their field of expertise and having some rich experience in conducting clinical trials. This speeds up the process of Investigators selection and ensures a reliable and accurate performance of clinical trials at the clinical sites.

Regulatory Submission

 

  • Regulatory submission for approval of Ministry of Health

  • Regulatory submission for approval of National Ethics Committee

  • Expedited Study Approvals

  • Local Insurance policies for patients

 

Our good reputation with the regulatory authorities ensures a reliable and obstacle-free submission of documents for clinical trial authorization at the Polish Drug Agency and Multi-Centre Ethics Committee.