Q?
How NovaTrials can assist me in my clinical trials efforts?
A.
Our useful experience with multiple hospitals and IRBs/EC allows us to select the most suitable sites for your study. Our proven systems and programs help accelerate recruitment and be more efficient through the different stages of the trial.
Q?
What are the advantages of carrying out our trial in Israel?
A.
Israel is globally recognized as a forward thinking innovator in medical development and the provider of quality healthcare and a community of medical professional and Key Opinion Leaders.
Q?
Do you deal with all aspects of contracts with the sites?
A.
Yes, we do. There is a whole process of contract negotiation including budget agreement and quality agreement. Using our experience in clinical trials and familiarity of each site, negotiation concludes in a brisk manner.
Q?
What are the requirements for quality agreements in Israel?
A.
Quality agreements are required only once per sponsor per site. A sponsor can conduct several clinical trials at a site under the same quality agreement.
Q?
Do you write protocols for phase 1 studies?
A.
Medical writing is part of our services for all indications from phase I to phase IV studies.
Phase I study protocols are more challenging yet, we at NovaTrials have vast experience in this field.
Q?
What kind of solutions do you have for Electronic Data Capture Systems (EDC)?
A.
Novatrials can provide a broad spectrum of solution tailored to your needs from Open-Clinica to Rave Medidata.
Q?
Is parallel submission accepted in Israel?
A.
Yes! According to the Israeli MOH guidelines, parallel submissions are acceptable (except for advanced therapy studies) and can definitely shorten the start-up timelines.
Q?
Are there QP release vendors in Israel?
A.
Yes, there are several vendors we are working with. Those vendors stand in international standards.
Q?
How do you handle translations?
A.
All translations are done according to the highest standards for clinical trials and outsourced to an approved vendor, using a translator and validator for each document. A confidentiality agreement is affirmed by all vendors prior to their approval.
Q?
Should all study documents be translated to Hebrew?
A.
No! Israeli MOH and Ethics committees accept English written protocols, Investigator Brochures, IMPD documents, CMC, IFU documents etc. Even The Clinical Trial Agreement and Quality Agreement with the clinical sites can be negotiated and executed only in English. The only documents that need to be translated to Hebrew are those that will be handed over to patients (Informed consent forms, questionnaires etc.) and the protocol synopsis.
