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Clinical Research Management & Monitoring

Poland

 

The Assign Group, an international pharmaceutical drug development enterprise with ~200 employees, supports pharmaceutical development from preclinical to clinical development. Our broad expertise in the entire development process and experience in all stages of product development will reduce your development time and support your project to become a success.

The Assign Group is an organization tailored to meet our clients’ individual requirements from preclinical & toxicology, scientifi c advice planning, development consulting, feasibilities, to project management and clinical monitoring, data management, biostatistics, pharmacovigilance, quality management, IMP handling services, central and analytical laboratory services, as well as medical writing.

Our IT platform uses ORACLE based systems, such as ORACLE OC/RDC, ORACLE Siebel CTMS, ORACLE AERS. In addition we offer our proprietory eCRF system InterTrial.

Our Expertise

Our particular expertise comprises clinical trials in vaccination, various oncological diseases, antibody development, autoimmune diseases, cardiovasculars and advanced therapies (personalized medicine, somatic cell therapeutics). 

Assign Group offers a “One-Stop-Shop” for all pharmaceutical development needs with highest quality and ethical standards to ensure for our clients the best possible services and products.

We offer our comprehensive services worldwide – and have local points of contact and knowledge right where you need it.

Project Management

Each of your projects is an investment in the future success of your development. The project manager is the key to successful project performance.

Assign Groups´s project managers have an understanding of your business needs and know how to effectively manage your projects to address these needs. We ensure that your projects will be completed to the highest quality standards, on time and within budget.

An experienced and dedicated Project Manager leads all aspects of your study – providing you with continuous feedback on recruitment, site selection, and how to run each phase – throughout the entire duration of your trial. And your project management team proactively monitors study milestones to ensure your trial is not only successful, but delivered on time and within budget.

In that spirit of partnership, our Project Managers take on the responsibility of being the single point of contact.

Monitoring

Experienced monitoring is the backbone of your clinical trial. Efficient monitoring services brings you fast subject recruitment, compliant site performance and reliable data. Our team ensures the adherence with standard operating procedures and strives to promote positive personal relationships with a high level of trust and confidence with all our customers.

Assign Group offers high quality and delivery based clinical monitoring services to manage a trial on time and within budget. Our experienced monitors provide a high level of expertise, efficient services and high end results to the pharmaceutical, bio-pharmaceutical and medical device industries.

Monitoring-Services offered include


  • Investigator Site Selection
  • Pre-study qualification visits
  • EC submissions/approvals
  • Site Initiation Visits
  • Organization of Training/Investigator meetings
  • In-house Monitoring
  • Clinical Trial Site Management
  • Clinical Trial Site Monitoring
  • Site Close Out Visits
  • Query Resolution

We have in-house training on a regular basis for clinical monitors to ensure the ongoing educational and knowledge increase of our people as per project requirements.

Company
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Assign Group / Assign Clinical Research Poland Sp. z o.o.

Zwycięstwa 10
44-100 Gliwice Poland