Management of study projects
Efficient Many years of experience in the study sector paired with professional expertise.
- On an equal footing Project manager with background, expertise and many years of professional experience in the field of ophthalmology/optics.
- Flexible You decide where the shoe pinches and what you would like to outsource; we will be happy to take over the tasks for you.
The success of a clinical trial stands and falls with the experience and coordination skills of the project manager. We are happy to take on this responsible task for you and provide our knowledge and expertise as a link between the sponsor, investigator and authorities.
We manage the processes involved in preparing and conducting the study and support the study project from start to finish. We record our work in a project management system in 15-minute steps for transparent cooperation and as proof of our performance.
Development of study concepts
With the introduction of the MDR, the requirements for studies have increased once again. Study planning is therefore very demanding in terms of the number of patients, duration of observation and selection of suitable endpoints, parameters and study hypotheses.
PMCF studies are a particularly exciting field, as they are required for most medical devices, but also offer interesting opportunities to generate data that can be used not only for regulatory requirements, but also for congress presentations, publications and brochure content.
The large area of PMCF studies in ophthalmology is our specialty. We are sure to work with you to find interesting study projects that fit into your budget!
Creating study documents
Study protocols must take into account many guidelines, regulations and laws. Patient information and consent forms are particularly demanding, as they must contain all relevant study information, but must also be understandable to laypersons and not be too long. The text passages on data protection also pose a challenge.
You can rely on our many years of experience and trained employees. We ensure that your study documents meet the legal requirements and still remain clear.
Selection of test centers
A good selection of trial sites and a selection of good trial sites are critical to the success of a trial. Of course, many sponsors are keen to place their studies with opinion leaders, but this can lead to studies progressing slowly as study teams are overloaded. With our global industry knowledge, we can help you recruit a good balance of trial sites, with fast recruiting and diligent sites and investigators who can skillfully present results at national and international congresses and are available as authors for publication.
Communication with trial centers, sponsor and authorities
The daily flood of information, usually by email, makes it difficult to separate communication related to tasks from purely informative communication. As a result, important information that requires feedback from the addressee may be lost and deadlines missed. Concise communication that is limited to the most important information helps the addressee to respond promptly and to make progress with their study preparations. Our team knows what is important and is trained in efficient communication.
Even though the way we communicate has changed in recent years, we pay attention to tone, politeness and even spelling and punctuation. Old school? No, but we are committed to correct interaction with our contacts in the industry, with clinics and medical practices and with the authorities. In our experience, we achieve our goals quickly with polite and efficient communication.
Submission to ethics committees and federal authorities
What does it mean when the ethics committee reviews according to BO §15, where has paragraph 23b gone and how do you submit PMCF studies according to MDR? We are experts in these questions and similar ones in other countries and will be happy to advise you.
Determining whether a study needs to be submitted to the federal authority starts with the conceptual design. This is where specialist knowledge is required in order to save a lot of time and money if necessary. Discuss the possibilities with us, we will be happy to advise you!
We are happy to advise you on the requirements of the MDR or certain ethics committees, obtain the documents from the study centers, prepare the applications, submit them and answer any queries.
Contract preparation and processing with investigators
Study contracts are complex documents that have to take many aspects into account:
- clear division of responsibilities
- Compliance with data protection due to particularly sensitive data
- clear rules on who owns the data and who is allowed to publish it and when
- Fair and legal cost reimbursement and remuneration according to fair market value
- Cancellation options and deadlines
- Confidentiality agreements
- The list could go on and on.
Investigators are often also customers of the sponsor. This makes it all the more unpleasant to discuss fees and obligations. We are happy to take on the role of mediator here. We will be happy to advise you on fair market value and all other points mentioned.
On request, we can draw up a study contract that is adapted to the respective situation and discuss it with both parties, sponsor and investigator or clinic administration.
Your processes are complex and you have concerns about whether the investigators are designing the invoices correctly, submitting them on time and being paid on time? We are aware of this problem and are happy to take care of payment processing for you. Our payment channels are clear, fast and very popular with trial centers.
Monitoring (on-site and remote)
Monitoring, whether on-site or remote, usually increases data quality. On-site monitoring is more intensive and the comparison with the data in the patient file is only meaningful and practicable in this way. Remote monitoring or risk-based monitoring is often the more sensible and budget-friendly option for post-market studies, provided the monitor has the necessary expertise. Our project managers and coordinators know their way around optics and ophthalmology. They are our data detectives and uncover inconsistent data, such as better uncorrected than corrected visual acuity and a smaller mesopic than photopic pupil. Many of these detective tasks are already automated, enabling fast and comprehensive data control. However, not everything can be automated - and this is where specialist knowledge comes into play.
There are many freelance monitors/CRAs. But do they also have the expertise that includes optics in ophthalmology? Our employees and network partners are trained and have many years of experience in ophthalmology.
Organization and moderation of auditor meetings
Our partner targoEvent® is specialized in events in the healthcare industry. All events with healthcare professionals (HCPs, HCOs) are carried out in accordance with regulations such as the MedTech Europe Code of Ethical Business Practice or the FSA Code on Working with Professionals. targoEvent’s creative ideas and experience enable events, such as auditor meetings, to be held in a pleasant setting that will be remembered fondly and still comply with regulations.
If a study is going very well, investigator meetings in the post-market area usually do not take place at all or only rarely. In our experience, slow patient recruitment is the main reason for investigator meetings in this area. It is difficult to criticize investigators, who are often also customers. We are happy to mediate for you or take over the moderation of investigator meetings and look for ways to solve any problems and achieve the study objectives.
We are there for you - whether virtually or at personal examiner meetings, whether at the weekend or during a congress.
Case number planning, data management and statistical analysis
Case number planning is useful for most studies and is now also required by many ethics committees. Valid case number planning is also advantageous for the sponsor: if more patients are included than required for the statistical hypothesis, the study will be unnecessarily prolonged and more expensive. If too few patients are included in the study, no conclusions can be drawn. Our experience shows that sponsors without their own statistics department are happy to make use of our expertise. We are familiar with the various methods and know how to research suitable references and use them appropriately.
While SPSS used to be the gold standard as statistical software in the medical field, there is now a strong trend towards “R“ due to its greater flexibility. SPSS may be easier to use, but our experts know and can use “R“ and therefore have a very wide range of analysis options.
There are special requirements in ophthalmology in particular, such as double angle plots for the vector display of toric lenses or other astigmatism issues. With the appropriate R programming, this is easy for us to implement. Higher-ranking peer review journals also often have high demands on the type of evaluation and graphical representation - here too, we can respond flexibly to the requirements.
Statistics is like cooking: only with good ingredients can something good come out of it. In statistics, the ingredients are the data. Our experience with data that we receive for evaluation shows that inconsistent data is still present even after the clean file has been declared. Adverse events are not recognized as such, refraction data changes in the wrong direction, spherical equivalents are calculated incorrectly, uncorrected visual acuity is better than corrected visual acuity and photopic pupils are larger than mesopic pupils, to name just a few examples. Subsequent adjustment is time-consuming and costly.
With our support, the data in Clean File is really “clean“. Our semi-automated plausibility check uncovers almost everything, our experts find the rest. Ideally, the data comes from our EDC system targoDoc, then everything is from a single source and a professional statistical evaluation is possible in a timely and cost-effective manner.