Presenationfolder_Sponsors and CROs
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Services for<br />
<strong>Sponsors</strong><br />
<strong>and</strong> <strong>CROs</strong>
Camovis<br />
Your partner<br />
Dr. med. Bettina Bergtholdt – Partner<br />
She is CEO of the emovis GmbH since<br />
2001. Emovis is a Site Management Organization<br />
<strong>and</strong> 50% partner of Camovis.<br />
Due to her long-time activities as a (Principal)<br />
Investigator, Dr. Bergtholdt disposes<br />
of distinct practical experience in clinical<br />
studies of phases I-IV.<br />
Carolin Kurth – CEO<br />
She is a trained nurse <strong>and</strong> possesses many<br />
years of experience as a Study Nurse.<br />
2011, she started as a Freelancer, in order<br />
to support study teams in seasonal peaks<br />
or with staff shortages. Due to her experience<br />
as a Flying Study Nurse at various<br />
study sites, Carolin Kurth comm<strong>and</strong>s over<br />
a lot of practical experience in planning<br />
<strong>and</strong> execution of clinical studies with various<br />
indications.<br />
H<strong>and</strong>s on expertise<br />
in performing<br />
clinical trials<br />
2
Our Service<br />
Flying Study Nurse<br />
Our service<br />
Our geographic range<br />
Your benefits<br />
04<br />
05<br />
07<br />
Site Support<br />
Our service<br />
Examples of worksheets<br />
Your benefits<br />
08<br />
09<br />
10<br />
Site Analysis<br />
Our service<br />
Example for Site Analysis Report<br />
Your benefits<br />
12<br />
13<br />
14<br />
3
Flying Study Nurse<br />
Our service<br />
Are your clinical trial sites experiencing a<br />
hard time to meet recruitment expectations?<br />
Do you need efficient support for<br />
every kind of non-medical but study-specific<br />
activities?<br />
Then play your joker <strong>and</strong> order your Flying<br />
Study Nurse now! We will support you<br />
with high quality <strong>and</strong> flexibility according<br />
to your needs.<br />
We support your study sites locally:<br />
Patient care <strong>and</strong> coordination<br />
Data collection <strong>and</strong> reporting<br />
Sample collection <strong>and</strong> processing<br />
Laboratory logistics<br />
Maintenance of all relevant documents<br />
Contact partner for inquiries<br />
4
Our geographic range<br />
Your clinical trial site is located a bit outside?<br />
No problem: Our portfolio of Flying<br />
Study Nurses is growing steadily. We will<br />
offer tailormade services for you in Germany<br />
<strong>and</strong> bordering areas.<br />
5
6
Flying Study Nurse<br />
Your benefits<br />
More study sites will agree to participate if they can resort<br />
to Camovis services<br />
Decrease of costs for sponsors by reducing monitoring<br />
needs<br />
Improved data quality at your study site<br />
7
Site Support<br />
Our service<br />
Well structured management, highly efficient<br />
tools <strong>and</strong> extraordinary interpersonal<br />
skills are key of our professional strategies.<br />
In combination with our long-term experience<br />
we will raise your clinical trial site<br />
performance significantly.<br />
We will support you with every kind of<br />
medical <strong>and</strong> non-medical, study-specific<br />
activities.<br />
We support your study sites remotely:<br />
Patient identification & pre screening<br />
Worksheets / source documents / tools<br />
Training <strong>and</strong> workshops in practical implementation<br />
of clinical studies<br />
8
Examples of worksheets<br />
The quality of the local study realization can be improved substantially, if source documents<br />
are individually tailored along the operational procedures of each study site.<br />
9
Site Support<br />
Your benefits<br />
Increased recruitment rates by pre-identification<br />
Improved data quality by using site specific worksheets<br />
Decrease of costs for sponsors by reducing<br />
monitoring needs<br />
10
11
Site Analysis<br />
Our service<br />
Are you conducting a clinical trial which<br />
does not deliver the expected results? Are<br />
you experiencing delays? Does that affect<br />
areas such as your project-related cost<br />
planning?<br />
Camovis will provide you with a detailed<br />
analysis to solve your problem.<br />
Questions are settled efficiently: Which<br />
deficits are given <strong>and</strong> what is the root cause.<br />
We can assist you to overcome your<br />
specific obstacles on the track to success.<br />
We support your study site in case of low performance:<br />
Analyse causes<br />
Provide solutions<br />
Support study site by detecting the problems<br />
12
Example for Site Analysis Report<br />
Camovis GmbH, Wilmersdorfer Str. 79, 10629 Berlin<br />
Site Analysis Report<br />
For study:<br />
Site:<br />
Description of the Study Site …<br />
Staff members at Study Site …<br />
Organization of the Study Site<br />
…At this step danger for loosing eligible patients seems to be high as there is no established<br />
procedure of how to proceed afterwards. It is not clearly defined, who is responsible to contact the<br />
patient, to inform the patient about the study participation <strong>and</strong> to schedule possible study visits. PI<br />
was advised to establish a procedure, for example to make a written list of patients, including<br />
information about the status of follow up. In addition, responsibilities for the following steps should<br />
be defined <strong>and</strong> clearly communicated with all staff members.<br />
Recruitment activities<br />
…Pre-screening activities at the site are well organized <strong>and</strong> intensive: Study Nurse is checking the<br />
data of all patients having an appointment during the next weeks for in- <strong>and</strong> exclusion criteria of the<br />
study. The applicable lists were available.<br />
Results of database check …<br />
Conclusion<br />
…The site seems quite disorganized <strong>and</strong> staff members are overworked. Staff members, except PI,<br />
are not really intereseted in increasing their own work load by including patients in the study. Even if<br />
they would be interested, the structure of the clinic inhibits effective work flows. The PI himself was<br />
quite interested <strong>and</strong> helpful, but does neither have the recources to do all the work on his own, nor<br />
the structures <strong>and</strong> staff to delegate the study work. The PI himself stated, that calling a patient for<br />
follow up is not possible, as “study work is not the main job they have to do”.<br />
Camovis GmbH E-Mail: info@camovis.de Bankverbindung:<br />
Dr. med. Bettina Bergtholdt · Carolin Kurth Telefon: 030 - 310 136 14 Berliner Volksbank<br />
Wilmersdorfer Str. 79 Fax: 030 - 310 136 15 IBAN: DE98 1009 0000 2510 5640 09<br />
10629 Berlin Ust.-IDNr. DE 294 505 081 BIC: BEVODEBB<br />
13
Site Analysis<br />
Your benefits<br />
More than 20 years of practical experience at sites<br />
with extended insight in site structures<br />
Transform inactive study sites to high performing<br />
study sites<br />
14
Camovis<br />
Do not hesitate to contact us<br />
Camovis GmbH<br />
Wilmersdorfer Straße 79<br />
10629 Berlin-Germany<br />
www.camovis.de<br />
Mail: info@camovis.de<br />
Office:<br />
Mobil:<br />
Fax:<br />
+ 49(0)30 310 136 14<br />
+ 49(0)160 954 950 05<br />
+ 49(0)30 310 136 15<br />
Carolin Kurth<br />
Dr. med. Bettina Bergtholdt<br />
15
Camovis GmbH<br />
Wilmersdorfer Straße 79<br />
10629 Berlin-Germany<br />
www.camovis.de<br />
Mail: info@camovis.de<br />
16<br />
Office:<br />
Mobil:<br />
Fax:<br />
+ 49(0)30 310 136 14<br />
+ 49(0)160 954 950 05<br />
+ 49(0)30 310 136 15