Services
Consultancy
Protocol / Study Design
Our significant experience and knowledge can help you plan a optimal study design. In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts. Let us be your bridge to the key opinion leaders and experts throughout Europe.
Timelines and Budget Planning
Controlling development timelines and budgets are essential for companies that want to bring a medical device to the market. Factory’s control systems give you all the information you need to keep you informed and stay in control of the process, every step of the way.
Patient Referral Services
With the support of referral network was developed to cooperate with both pharmaceutical companies, CROs and SMOs to aid the fastest and most successful recruitment in different kind of therapeutical areas. With our rreferral partners in our database, we are able to find potential subjects for orphan indications as well. One of our strengths is that our data are refreshed monthly by our referral partners which enables us to provide the most current information to our clients. With the Optimusmed program you will be able to accomplish patient recruitment and enhance the patient retention of the study within the earliest time possible.
Project Management and Monitoring Services
Our clinical team guarantees up to date knowledge of your trial status at each participating hospital. They have extensive experience and knowledge in all phases throrough the entire steps of the clinical trial, with on-site and remote monitoring including Risk Based Monitoring activities, CAPA, regulatory Inspections and routine audit preparation and follow up.
Trial Document Handling
During a clinical investigation it is important to define the procedure for set-up, maintenance, regular review an archiving
of all the study documents in the Trial Master File. This is a service offered by us that individually and collectively
permits evaluation of the conduct of a trial and the quality of the data produced, and which complies with the standards of
ISO14155 and with all applicable regulatory requirements.
We offfer also a uniqe service to implement electronic TMF environment, where all of roles are being given restricted access
based on the responsibility level.
To transform the still paper-based economy and its processes into a 100% digital platform while retaining the legal effects
and security features of a paper-based economy. We have a solution for both companies and individuals and we are capable of
connecting these two segments.
Our philosophy says that we don’t need paper, we need the information on it!
With our business partner we provide a unique application to give everybody – from the higher management to the CTAs – a tool that can store and forward the legally original and digitalised documents. With this tool it is possible to create a legally AUTHENTIC digital copy of any existing or new document that will be identical with the original, in this way there is no need to print out or store the official documents.
