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Presenationfolder_Sponsors and CROs

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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

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