Phase I-IV services

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 14 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 10 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.

Case Study

HungaroTrial cut project time by one year
A US Sponsor launched a clinical project in PAO in the US, South Africa and Brazil. The enrollment rate was far below the original plan; therefore the company approached HungaroTrial to open up new trial sites in three countries in Central and Eastern Europe. The productivity of HungaroTrial’s sites was four to five times higher than that of the original sites, enabling the Sponsor to save a full year.

A US-based biotech company initiated a Phase I clinical trial to develop a compound for the treatment of Peripheral Arterial Occlusion. The study involved eight dose escalation cohorts with 18-22 patients each. Only the US, South Africa and Brazil contributed to the first cohort, which took 239 days to close. Among cohorts 1 to 4, the average time to close one cohort was 157 days. Since this enrollment figure was far below the expectations of upper management and the company's investors, the Sponsor decided to extend the project to three Central and Eastern European countries with the help of HungaroTrial.

HungaroTrial managed to set up new trial sites in Hungary, Serbia and Romania within a short time; in all, nine new sites from these countries joined cohorts 5 to 8 of the project. Of the nine new sites, seven (or 78%) was able to actively enroll patients to the study, significantly exceeding activity rates of less than 30% in other parts of the world.

Due to the high activity and productivity of the trial sites managed by HungaroTrial, the average time to close a cohort was reduced from 157 days to 64 days. This way, HungaroTrial made it possible for the Sponsor to save one year of development time.

Testimonal

"Having worked with many CROs over the last ten years, I would rank HungaroTrial at the top of my list of companies to work with."

Sue Kusek
Director of Clinical Research
NPS Pharmaceuticals
USA


Copyright: HungaroTrial 2014