CLINICAL OPERATIONS
Many trial centers are under pressure: staff shortages, high demands, and limited resources make it difficult to conduct clinical trials in a structured and high-quality manner. The result: delays, increased team workload, and risks to study quality and patient care.
Ready to go
With our patient-focused clinical service, we provide experienced Clinical Research Professionals, either directly at your trial centers or at the patient's home. The Clinical Research Professionals take on essential tasks as part of study visits and patient care – flexibly, efficiently, and in compliance with regulations. Hybrid and decentralized care scenarios are an integral part of our services.
Whether it’s vital signs, ECGs, blood draws, IMP handling, sample logistics, or support during visits, our team supports and complements your staff, fills gaps, or temporarily takes on entire roles. In addition, we assist your patients in using eDiaries and wearables. Whether on-site or remotely, we ensure secure data generation and data collection.
You benefit from:
- Effective support and faster completion of your clinical trial – We take on essential tasks and fill staffing gaps to ensure that the study is completed.
- Structured and patient-centered processes – Professional support improves the quality of care, positively impacting compliance and the timely availability of reliable study results.
- Relief for trial center staff – The workload on the team is reduced, planning for the trial site and sponsor is improved, and on-site staff satisfaction is increased.
Case Study: Support for a phase 1 study
Initial situation:
A trial center is conducting a phase 1 study with a new active ingredient. In this early clinical development phase, closely timed blood sampling and laboratory analyses are essential in order to accurately record the pharmacokinetics of the drug. During each study visit, multiple blood samples must be taken from the subjects at short intervals, processed immediately, and sent to central laboratories. This requires precise coordination and complete documentation. The trial center's laboratory team is already working at full capacity and cannot handle the additional requirements of the study without delays or possible sample losses.
Solution:
Our clinical Research Professionals are specifically deployed to provide laboratory support. They take care of the entire sample logistics process – from collection and immediate processing to timely shipping. They adhere strictly to predefined time windows, centrifuge and aliquot samples immediately after collection, document all steps in accordance with the study specifications, and organize the safe transport of samples in compliance with all storage and shipping regulations.
Result:
Thanks to professional support, laboratory processes run smoothly and without delays. All samples are collected, processed, and shipped strictly within the required time frame, ensuring that pharmacokinetic analyses can be carried out as planned. The test center is able to meet the requirements of the phase 1 study without overburdening its permanent staff. The sponsor receives complete and usable data, while the center uses its resources efficiently and at the same time maintains the quality of the study implementation.
