You’re competing for patients and competing for market position. In some instances, you’re competing for your company’s survival. We get that. Our expertise is highlighted in the next section, which is the special sauce for building effective solutions. We foster an environment of collaboration among all our teams and management. It’s all for one and one for all. You benefit when we work together to develop the right solution for the project: it’s an easier project to run and stays true to timelines and budgets. From what we hear, that is mighty important these days.
B. Brown, Director of Clinical Operations, Biotech Company
As an organization that specializes in outsourcing management, we have built a portfolio of specialty service providers that offer you the niche expertise desired for critical stage projects. Our model employs a harmonized project management approach with streamlined contracting options for international programs. The result provides you with a fast-moving, flexible, highly specialized solution without excessive overhead or management bureaucracy.
Stiris is committed to proactively managing your clinical study from beginning to completion. We provide a single point of contact with the expertise to confidently manage all aspects of your study including:
Even with the most careful planning, sometimes projects don’t work out as expected. Many reasons can contribute to jeopardizing a trial: recruitment lags behind, monitoring is delinquent, data quality is questionable, site relationships are damaged, providers’ resources aren’t adequate to fulfill obligations, etc.
When you find yourself in ‘rescue’ mode, you need a partner who understands all the delicacies involved with getting a project back on track. Stiris has been recruited to manage the rescue of over 50 trials. Our team has the knowledge and expertise to work with you to design and implement a rescue strategy, rebuild and strengthen site relationships, and get trials moving in the right direction. That doesn’t happen by chance, it happens with purpose, accountability and teamwork.
A client brought up the Three Musketeers reference ‘All for one and one for all’. While we joke about it – it really is what you get. There are times when speed is critical, like when a third of your sites won’t get a close out visit because your “preferred CRO” doesn’t have personnel available. We understand the stress placed on you by management, which is why we mobilize the way we do to make it happen.
Stiris Project Managers are all strong leaders, who have developed their skills over many years in clinical research as CRCs, CRAs and Project Managers. Over 40% of our team has held executive positions in Pharmaceutical, Biotech and CRO companies. As part of your team our Project Managers:
Clinical Monitors are the front line of clinical research. At Stiris, our team of CRAs doesn’t just monitor your study, they manage the sites. The CRAs are pivotal in determining a study’s success (as measured by recruitment, data quality and issue management). The Stiris team of knowledgeable CRAs will ensure the sites are supported and motivated to provide the cleanest data possible in the shortest time possible.
All CRAs are trained to our extensive SOPs to ensure quality and consistency of services such as:
Stiris’ safety team provides a comprehensive range of Medical Affairs and Pharmacovigilance services throughout the product life cycle. The Medical Monitor is an integral partner throughout the trial, collaborating across functional units to assist you in effectively managing your drug safety information.
Medical Affairs and Pharmacovigilance Services include:
The company you have come to rely on for your clinical trial management needs also provides auditing services in the way Stiris is known for: with quality, collaboration, and while keeping you safe.
Stiris’ data management and statistics team has successfully supported over 150 clinical trials including early phase studies, large pivotal studies, as well as multiple late phase studies.
Clients both large and small have recognized the strategic benefits of working with our customer focused team and market leading technology. Some of the qualities that significantly differentiate us include:
Clinical Data Management Services include:
Whether you’re running your study in North America, or globally, we have you covered with expertise in:
Your Stiris team is dedicated to rapid site activation. Our specialists review each study and individualize the start-up process to address your protocol’s specific needs to ensure the most efficient and effective structure for your study.
Stiris’ start-up services include:
Stiris is strategically designed to allow you to run your trials globally while retaining quality of people and regional expertise. Global coverage by a team where your business is important to each of us; where you’ll stay in the forefront and continue to be supported by great teams. Where your important study is our important study.
Stiris’ collaborative model gives you access to first-in-class global coverage in every service we provide. Our innovative approach affords you proven solutions without compromising quality.
We designed this cost-effective solution to meet growing client demand while retaining our nimbleness to change direction quickly. There is a seamless connection between partners so you retain that single point of contact. Take advantage of our extensive global experience, use of best practices and flexible contingency planning to effectively manage your studies.
Clinical Trial Management Software and Electronic Trial Master Files
Stiris’ Clinical Trial Management System (CTMS) allows you instant access to up-to-the-minute information on the status of each trial. Key features of the CTMS include: