Novatrials’ broad spectrum of services offers you the highest standards of quality and best clinical practice, while always sticking to your budget and your timeline.
Our experience is spread across the following trial categories:
- Pilot/feasibility/FIH (First in Human)/early phase (I) clinical trials
- Pivotal/late phases (II-III) clinical trials
- PMS (Post Marketing Study)/phase IV clinical trials
Whether you need support with your project as a whole, or modular services to meet a specific need, we have the solution you are looking for.
Every clinical development program relies on having the proper paperwork and documentation. Regarding the study itself, proper planning of the research documents will have an affect on the decision making of the regulatory bodies, the reimbursement aspects of the research and the ability to properly analyze the results of the research upon completion. It will also ensure that the team of doctors, nurses, research coordinators and other internal hospital staff are able to implement the protocol, and carry out the research without mistakes or deviations that could endanger the safety of the study participants and the quality of the results.
Having high quality paperwork will also prevent unnecessary correspondence and explanations with research approval bodies, and avoid delays and interruptions caused by having to make corrections and rewriting. Furthermore, your professional documents are what stand behind your company, giving you credibility when you talk to investors, regulatory bodies and others.
In short, taking appropriate care over the writing of your study documentation will maximize the likelihood that the research will succeed in achieving its goal.
The Novatrials team of expertly trained medical writers combine a broad range of experience – academic, pharmaceutical, clinical research and scientific – to meet all your medical writing needs for pharma, medical device and advanced therapy trials. Presenting the material clearly, concisely and precisely, we’ll make sure that every customized plan and report says exactly what needs to be said, leaving no room for doubt as to what you mean, and suits the audience for whom it is intended.
Our comprehensive suite of medical writing services includes:
- Study Protocol
- Clinical Investigational Plan
- Instruction for Use (IFU)
- Informed Consent Forms and Patient Information Sheet
- Lab Manuals
- CSR- Clinical Study Report
At Novatrials, we accompany our clients through every step of the clinical development process, from designing the clinical research, selecting the center where the study will take place and recommending relevant key opinion leaders in Israel, through site staff training, monitoring the collection of data, obtaining reliable and qualitative information, ongoing reporting and writing up the relevant findings, all the way through to summarizing your study in a high-quality report, ready for your next step.
- Site Selection
Novatrials has established relationships with almost every research center in Israel. We use our previous experience to identify and connect you with an organization and team that will suit the needs of your specific study, in terms of knowledge requirements, staff experience, research facilities, timetable, and more.
- Clinical Trial Agreement and Study Budget Management
The Novatrials’ priority is to represent your best interests, at all times. We understand how to work within your budget throughout the research. Also, while negotiating contracts and budgets with the selected clinical sites, we employ effective work methods that shorten contract approval times.
- GCP/ISO14155 Audit Preparation
At the end of 2016, Novatrials was the subject of an FDA review of the research under our supervision. The quality of our work was confirmed by the FDA inspection, with zero finding. No FDA Form 483 was generated, as reflected at FDA website in the following link: https://www.accessdata.fda.gov/scripts/cder/cliil/dsp_Search.cfm.
You can therefore have confidence that when we help you to prepare for a qualifying study, audit or review, you are in excellent hands.
- Training for Site Staff and Investigators:
Novatrials works with the medical staff at the trial site to ensure that they receive training related to their specific role in the research. This includes knowing how to coordinate the relevant hospital units as required by the research, which may be different to their usually way of cooperating.
Novatrials offers all types of monitoring, including: pre-study visits, site initiation visits, on-site monitoring and site closure visits. Our experience also covers all newly recognized monitoring settings, from remote monitoring to risk-based monitoring using comprehensive electronic systems.
When Novatrials manages your project, whether it takes place in Israel or overseas, you get the advantage of having a single point of contact throughout the life of your study. Amongst other things, the role of your project manager will include: clinical study related risks and mitigation plan; kick-off meeting; ongoing reporting and discussions; ensuring all parties are well trained, stay updated and adhere to study requirements; and budget management. Above all, you get a partner who thinks with you and generates solutions rather than only pointing out the challenges.
Deeply familiar with all relevant guidelines and regulations for clinical trials in Israel and abroad, at Novatrials, we take care of all your trial’s regulatory processes, saving you time, resources and inconvenience. Our comprehensive range of regulatory affairs support includes RA and IRB/ECs submissions, and consulting services, all of which are prepared with the utmost care and attention to detail so you can rest assured that the regulator has all the information they need to make a favorable decision.
Data Management and Biostatistics
We at Novatrials know the importance of data integrity in achieving good clinical practice throughout your trial. Combining years of therapeutic expertise and the latest technology, we provide a full data management service covering: set-up of case report forms; set-up and validation of clinical data base; statistical programming; medical coding; data cleaning; biostatistics; randomization; sample size calculation; statistical consulting; electronic and paper-based data capture; database design and integration; data entry, review, and query resolution;; serious adverse event reconciliation; remote data coordination; external data integration (batch uploads); customized status and metric reporting.
We are also able to organize your database and collected data according to the CDISC (the Clinical Data Standardization Consortium) standards, right from the start.
As experts in clinical biostatistics and regulatory requirements, we leverage clinical data analysis to optimize the design of your study and bolster its success.
When you work with Novatrials, you can rest assured that we are fully committed to patient safety and regulatory requirements for all safety reports. Managing pharmacovigilance in strict adherence to all relevant regulations, we will take the necessary steps to collect, detect, assess, monitor and report safety data of your Investigational product.