Our ServicesBlueskin offers all aspects of protocol development and clinical operations
Our clinical methodology experts are highly experienced in guiding optimized protocol design in both traditional (site-based), hybrid and fully decentralized study designs.
As a science-driven organization we leverage our in-house research and proprietary clinical trials database for success.
Blueskin has gained a track record of rapid initiation and recruitment of patients, unsurpassed by any other research company, using our unique feasibility approach FeasIntel™ and a well-established clinical trial site network.
We use a technology platform developed by our affiliate, Studies&Me, for recruiting patients and evaluating them through remote assessments. This allows us to perform a speedy recruitment with a low screen failure rate.
Trial & Project Management
Our clinical trial management team strives to deliver results efficiently, on time, and within budget, while maintaining our high-quality standards.
From protocol design to final reporting, our team will support your projects to ensure successful outcomes.
The limited number of sites we require for even large phase III trials, and our specialized scientific approach, ensures we can generate high quality data quickly and efficiently, saving time in seeking drug approvals.
Risk-Based Monitoring & Data Management
Our employees are well educated and equipped to oversee clinical trials at any level desired by our partners.
Our processes are all up to industry- and regulatory standards for a risk-based approach to clinical trial conduct.
As experts in risk-based monitoring, with over a decade of hands-on experience, we have a proven track record of successfully conducting and reporting high-quality projects.
Our intelligent approach combines various monitoring techniques both centrally and on-site and is supported by internal teams. This enables us to quickly identify any quality- or safety concerns across trial sites and detect unusual patterns that may be missed through manual review.
We are recognized in the industry for our expertise in risk-based monitoring, having published several research papers on the subject.
Regulatory Affairs and Pharmacovigilance
Our familiarity and expertise with local regulatory agencies and procedures allow for quick approval of clinical development programs.
We have a thorough understanding of obtaining regulatory approvals from both regulatory agencies and ethics committees for clinical trials of new substances, medical devices, etc., as well as keeping these approvals updated with amendments and annual revisions.
We have extensive experience with the EMA, FDA, MHRA, CFDA, ANVISA and many other competent authorities and ethics committees globally and know how to meet their requirements for a swift regulatory approval.
As a knowledgeable and continuously learning organization, we stay up to date with all guidelines and regulations, including preparations for the new EU Clinical Trial Regulations and CTIS.
Patient safety, medical oversight, and regulatory compliance are some of our priorities in clinical trials. We collaborate with our partners' drug safety departments to provide safety monitoring and prompt reporting of adverse events worldwide.
Blueskin ensures the quality, reliability, and accuracy of data for all clinical trials we conduct, by working after a quality management system that adheres to ISO 9001 standards. We focus on patient safety and risk management, and our internal audit team is dedicated to performing assessments and hosting audits from our partners.