- Project Management
- Study Planning and Feasibility
- Site Selection and Support
- Site Monitoring
- Regulatory and EC Affairs Management
- Hospital and Investigator Grant Negotiation
How we Overachieve in Project Management
1. We train harder
HungaroTrial hires only the most talented and experienced project managers in the industry. Then we further enhance their skills with internal, customer-centric training ensuring truly unsurpassed service for our clients. Finally, we match your project with a project manager whose background and skills best match your requirements.
2. We communicate more clearly
Our project managers act as the link with the sponsor to ensure clear, concise communication and on-time performance every time. They are committed to maintaining flexibility and cost management. And as leaders of a multidisciplinary operational team, they are empowered to oversee every aspect of clinical trial management, handling changes and new objectives as they arise. Your project manager will be your single point of contact for every aspect of planning, coordination, compliance and operations.
3. We innovate further
Our project management teams are supported by innovative clinical tools and systems, which provides a variety of reports with up-to-date study information. These customized reports enable project managers to anticipate the next step in the study process and proactively handle potential issues.
How we Overachieve in Study Planning and Feasibility
1. We see into the future more clearly
HungaroTrial understands that proper planning is key to conducting a successful trial. Our knowledge of the region, our specialty areas, and clinical research in general helps us spot potential trouble in the planning stages and plan to avoid it.
2. Our questions are tougher
Comprehensive feasibility questionnaires drive good planning. Without clear, comprehensive answers from the field, feasibility is just a guess. At HungaroTrial, we don’t guess.
3. We know more about more patients
The proprietary HungaroTrial clinical research database is an unusually powerful planning tool. We know where the patients will come from well before the study starts, so our sponsors know enrollment timelines will be met and the trial will start on time.
How we Overachieve in Site Selection
1. We know more about more Investigators
After 18 years in business, we’ve met them all. The good, the bad, and the KOLs. We will search our extensive investigator/ site database for the right location, staffing, qualifications, history, clinical trial experience, area of therapeutic experience, GCP/ICH compliance and patient population/enrollment history. And because we have enduring relationships with these physicians, your study can start up quickly and smoothly.
2. We document expectations more thoroughly
We ensure efficiency at study start-up by providing a comprehensive binder to the site, detailing the required documentation for your study. We prefer to select clinical investigators we are familiar with to ensure fast turnaround for regulatory document processing and excellence in project execution.
3. We build more meaningful relationships
People overachieve for people they like and respect. Sites overachieve for the same reason. So at HungaroTrial, we focus on constant communication and training with our sites. It all pays off when these sites return on sequential studies, resulting in significant time and cost savings that we pass along to you.
How we Overachieve in Site Monitoring?
1. We commit more resources
Great results require great commitment. To maximize our monitors’ ability to focus on your study and produce the best results, we strive to assign them no more than two studies at a time.
2. We are more flexible
HungaroTrial provides monitoring around the CEE region. Our decentralized workforce allows us to maximize flexibility, reduce travel costs, and create an efficient and cost-effective monitoring process.
3. We hire smarter
Every one of HungaroTrial’s Clinical Research Associates (CRAs) were carefully selected for their therapeutic expertise and clinical research experience. We seek out monitors with the best credentials in these areas because we know they are critical to the success of your trial.
How we Overachieve at Regulatory and EC Affairs Management
1. We have better relationships with local regulators
Any CRO can read the local regulatory expectations, but only an experienced local provider can effectively help you with important details like adapting an Informed Consent to local standards in the many areas around our region. HungaroTrial knows which phrases are preferred by the Competent Authority and Ethics Committees, and which expressions will raise questions. More HungaroTrial projects are approved the first time — avoiding time-consuming change requests.
2. We have a deeper understanding of local regulations and laws
HungaroTrial maintains a full and up-to-date collection of the local regulations and all the related legal documents. Local lawyers are involved in this process. This is a frequently changing legal environment – but HungaroTrial keeps pace better than any global CRO can.
3. We are more proactive
If any aspect of your clinical trial application or project could be questioned by the authorities, we will always suggest a proactive consultation with them and manage it on your behalf. Being proactive with regulators avoids costly setbacks in the application procedure.
How we Overachieve at Hospital and Investigator Grant Negotiations
1. We use more innovative payment structures
Traditional per patient fees get traditional results. At HungaroTrial, we often use more creative payment terms to motivate investigators and spur higher enrollment.
2. We’ve done our homework
During 18 years in the CEE, HungaroTrial has worked with most of the region’s hospitals. That means there’s a good chance we have previously negotiated a contract template we can use for your project. Our library of contract templates can save you the time and expense of starting from scratch.
3. We use more specialized contract managers
Let’s face it: negotiating contracts among multiple parties in multiple legal jurisdictions can be messy. When negotiations threaten to get tricky, we bring in specialized contract lawyers to smooth the process.