palleos healthcare

Taunusstrasse 5a
Wiesbaden, 65183
Germany

Phone: +49 611 950190 0
E-Mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

Description:

palleos healthcare is your clinical trial expert in Europe.

palleos healthcare is a central European full-service Clinical Research Organization (CRO) focused on product development including pre-clinical consulting and clinical services for small to large scale trials. More than 74,000 patients in 2,100 sites have been treated throughout various indications.

The many years of experience of palleos healthcare makes it possible to provide customized services during the start-up phase, followed by consulting and project management during the preclinical and clinical research phase. 

Through our cutting-edge project management and working with our established network of collaborators, we accelerate the journey towards overcoming public health challenges, today and tomorrow. With strong local expertise and focus on quality, palleos healthcare ensures seamless clinical trial conduct and drug registration, on time and within budget.

palleos healthcare provides a full range of high-quality CRO services for Phase I-IV, BE and RWE studies, with expertise in 29 therapeutic areas. From initial planning to study closure, we offer comprehensive expertise across all facets of clinical research ensuring precision and tailored solutions for every stakeholder involved.

We are committed to providing flexible service options for our clients, who may choose to outsource to us only a part of management of the clinical trials: regulatory submissions, logistical support, medical GCP-compliant monitoring, medical writing, QA/Co-monitoring. Importantly, we can rapidly join a study at any stage to provide fast patient recruitment when the study falls behind schedule.

Clinical Trial Services

Medical monitoring and project management

Staffing

• CRAs, Lead CRAs, Project Managers, Regulatory Officers, Logistics Coordinators, and CTAs

Regulatory support

Regulatory support for clinical trials in Europe:

• Established regulatory interface with the authorities
• Submission to health care authorities, central and local ethics committees for approvals to carry out clinical trials
• Regulatory consultation
• Obtaining permissions to destroy remaining investigational product
• Certification of imported equipment
• Translation services
• Marketing authorization

Finance Management

• Financial project planning
• Grant payments to the medical researchers
• Payments to the clinic administration
• Designing and managing contracts with clinic administration and investigators
• All customs payments during clinical trials
• Supporting the finance budget for clinical research
• Negotiating purchase of additional equipment, accompanying materials, and various supplies
• Any other finance support

Insurance policies

• Obtaining insurance for patients and investigators’ liability for participating in studies
• Obtaining insurance for the medications under research during their transportation to the country of research
• Obtaining insurance for the medications during their storage in clinics or at a centralized warehouse

Logistical Support

• Obtaining import and export licenses for investigational product and biologic specimens
• Preparation of documents for customs clearance
• Customs clearance of the cargoes
• Allocation and transportation of the cargoes
• Tracking of the cargo during delivery
• Providing the insurance of the cargoes and carrier responsibility if necessary
• Delivering all clinical trial materials and medications to the research centers
• Temperature tracking in cool-chain delivery
• Shipment of biosamples to a central laboratory
• Purchasing and distributing additional equipment, various accompanying materials and supplies

Distribution and Drug Storage

Outsourced warehouse facilities in all countries of activities of OCT include:

• restricted, computer-controlled access to the storage spaces
• quarantine chamber
• fully computerized temperature and humidity control
• warehouse facilities allow to store medications at different temperature modes, research protocol conditions and sponsor requirements
• multiple refrigerating modes from +8 to -10 , from -10 to -40 , from -40 to -86
• alarm systems with preset values responding to power outages and temperature fluctuations
• providing daily graphs, others

Investigators’ Meeting Organization

• Inviting and summoning all investigators and representatives of the research sponsor
• Working out the meeting schedule, advertising materials and other supporting tools
• Translating materials for the meetings
• Offering all required working materials of the meeting to the investigators
• Preparing presentations
• Selecting convenient venues, including workshops and banquettes
• Negotiating contracts with service personnel
• Hotel reservations, visa support, traveling assistance
• General administrative support
• Arranging for audio- / video- equipment, Internet access
• Simultaneous translations

Quality Assessment

• Providing accuracy and compliance to GCP and country-specific regulatory, applicable SOPs of data
• Maintaining SOPs, conducting QA of sites and subcontractors
• Organizing sponsors audits
• Others

Medical writing

• Design and preparation of Investigator brochures, Study protocols, Case report forms, Informed consent forms, other study related documents in compliance with federal/local requirements, ICH-GCP, FDA /EMEA standards is done by our team of 6 highly professional medical writers.

Last update of this entry: July 15, 2024