Crocus medical 2015

1. Crocus Medical BV
(The Netherlands)
Professional CRO
10 years in Clinical Trials

2.  Crocus Medical BV is a Netherland Clinical
Research Organization registered in Amsterdam at
the Chamber of Commerce under Nr. 34210943.
 Crocus Medical BV was founded by Ms. Els van
der Linden and her colleagues in the Netherlands
in 2004.
 Ms. Els van der Linden is a notable person in the
world of international clinical research. In 1988
she became a General Manager and co-owner of
the Medical Information and Research Assistance
Institute (MIRAI), a Dutch CRO providing
services for the pharmaceutical industry.
CROCUS Medical BV history (2)
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What is Crocus Medical BV?
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts

3. 3
CROCUS Medical BV history (2)
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Crocus ancestry
Introduction
About
company
Areas of
activities
Advantages
Completed
cases
Contacts
MIRAI
• By 1998 MIRAI
grew to a company
with 450
employees
operating in 13
countries including
the Netherlands,
Belgium, UK,
Germany, Japan,
France and
Norway
Worldwide
American CRO
• In 1998 MIRAI was
sold to leading
American CRO and
Els van der Linden
became the director
of the Benelux,
Scandinavia and
Eastern Europe for
worldwide US CRO.
Crocus Medical BV
• In 2004 Els van der
Linden returned to
clinical trials with
Crocus Medical
BV. It was
established
especially for
operations in CIS
countries.

4. 4
CROCUS Medical BV - founders
Founders of Crocus Medical BV are all members of a group of highly professional
Dutch specialists in the medical science and practice.
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Background: Founders
Mrs. Els van der Linden
Founder of Medical Information and
Research Assistance Institute (MIRAI)
Mr. Peter Kunst
Former CFO of World Wide CRO
Prof. Dr.Dick Knook
Institute for Experimental Gerontology,
Rijswijk, The Netherlands
Prof. Dr.Kees Klinkhamer
Chief of Radiology department of
University Medical Department at
Utrecht, The Netherlands
Prof. Dr.Kees Kluft
President of international society for
Fibrinolysis and Proteolysis (ISFP),
The Netherlands
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts

5. Crocus Medical BV: Location
Location of branch offices:
Almaty
(Kazakhstan)
Moscow
(Russia)
Amsterdam
(The Netherlands)
Yerevan
(Armenia)
Crocus Medical B.V. has more than 50
employees, located in Amsterdam, Moscow,
Almaty and Yerevan offices

6. Areas of activities
The main activities of Crocus
Medical B.V. are conducting
of clinical trials, recruitment,
outsourcing and training of
clinical research personnel.
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts
Conducting
of clinical
studies
Recruitment and
outsourcing of
clinical trial
professionals
Training and
seminars in
clinical trials
In next slides we will
provide a more detailed
focus on our services

7. Areas of activities:
Organization and Conducting Clinical Trials
Conducting
clinical trials
Recruitment and
outsourcing of
clinical trial
specialists
Training and
seminars in
clinical trials
Crocus Medical BV can fully
conduct clinical trials or
partially support ongoing
studies.
Please see next slides for
the studies conducted by
Crocus Medical BV

8. Conducting Clinical Trials: Services
Partial Support of Clinical Trials
• Study set-up, regulatory and ethical approval
•Site selection out of own investigators' database
•Site Management
•Patients' randomization service
•Monitoring and QA visits
∙ Medical writing
∙ Legal and bookkeeping support in clinical trials
(agreements, payments to the hospitals and physicians etc)
∙ Data entry and management , statistic services,
statistical and study reports writing
∙ Payments to patients during BE and Phase I
studies
∙ Legal protection of the study parties
Full Clinical Trial Services
• Conducting complex projects, including
phase II, phase III and phase IV studies and
low-interventional studies
• Organizing & conducting the Investigator
Initiated Trials (IIT)
•Organizing of Registries for scientific and
medical associations & societies

9. Crocus Medical BV:
Completed Clinical Trials
THERAPEUTIC AREA/ INDICATION PHASE
NR. OF
SUBJECTS
SERVICES PROVIDED BY CROCUS MEDICAL BV
Hematology/transfusional iron
overload in MDS, thalassemia and
other anaemia patients.
IV 111
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Central Laboratory, Trial supplies, Safety reporting,
Insurance, Project Management, Statistical report, Clinical Study report
Oncology/marginally resectable
Gastrointestinal Stromal tumors
(GIST)
II, Investigator
Initiated Study
25
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Safety reporting, Project Management, Clinical Study
report
Endocrinology/International Diabetes
Management Practices Study
Registry of
Disease
810
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Initiation of the sites, Monitoring of the sites, Close-out of the
sites, Project Management, Safety reporting
Hepatology/HBeAg-negative chronic
hepatitis B
Product
Registry
76
Medical writing/translation (Protocol, ICON, CRF etc.), Monitoring, Safety
reporting, Project Management, Statistical report, Clinical Study report
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts

10. Crocus Medical BV:
Completed Clinical Trials
THERAPEUTIC AREA/ INDICATION PHASE
NR. OF
SUBJECTS
SERVICES PROVIDED BY CROCUS MEDICAL BV
Hematology/Diagnosis of CML
Registry of
Disease
6000
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Safety reporting, Project Management, Statistical
report, Clinical Study report
Endocrinology /Children, adolescents
and young adults with type-1
diabetes mellitus
Registry of
Disease
500
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Initiation of the sites, Monitoring of the sites, Close-out of the
sites, Project Management, Safety reporting
Oncology/Metastatic hormone
refractory Prostate cancer patients
Product
Registry
211
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Safety reporting, Project Management, Statistical
report, Clinical Study report
Oncology/Breast Cancer
Product
Registry
198
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Safety reporting, Project Management, Statistical
report, Clinical Study report
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts

11. Crocus Medical BV:
Completed clinical trials
THERAPEUTIC AREA/
INDICATION
PHASE
NR. OF
SUBJECTS
SERVICES PROVIDED BY CROCUS MEDICAL BV
Gastroenterology/H. pylori-
associated diseases
Product
Registry
3251
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Safety reporting, Project Management, Statistical
report, Clinical Study report
Endocrinology/International
Diabetes Management Practices
Study-II
Registry of
Disease
1200
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Initiation of the sites, Monitoring of the sites, Close-out of the
sites, Project Management, Safety reporting
Nephrology/Mineral and bone
disorders in Chronic Kidney
Disease (CKD) stage 4, 5 and 5D
Registry of
Disease
50
Medical writing/translation (Protocol, ICON, CRF), Collection of the dossier for
submission to MoH & EC, Initiation of the sites at the meeting, Monitoring of
the sites, Close-out of the sites, Project Management, Statistical report, Clinical
Study report, Safety reporting
Gastroenterology /Acute
diarrhea in children
Registry of
Disease
200
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Safety reporting, Project Management, Statistical
report, Clinical Study report
Hepatology/ Liver conditions
(chronic viral hepatitis, hepatic
staetosis, hepatic disease
related to diabetes or obesity)
Product
Registry
1500
Medical writing/translation (Protocol, ICON, CRF etc.), Collection of the dossier
for submission to MoH & EC, Initiation of the sites at the meeting, Monitoring
of the sites, Close-out of the sites, Project Management, Statistical report,
Clinical Study report, Safety reporting
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts

12. Crocus Medical BV:
Completed clinical trials
THERAPEUTIC AREA/ INDICATION PHASE
NR. OF
SUBJECTS
SERVICES PROVIDED BY CROCUS MEDICAL BV
Gynaecology/Climacteric
Syndrome in Menopause Women
Registry of
Disease
289 Statistical report, Clinical Study report
Endocrinology /Diabetes Mellitus
Type 2 in Adult Population
Registry of
Disease
1000
Medical writing/translation (Protocol, ICON, CRF), Initiation of the sites,
Monitoring of the sites, Close-out of the sites, Project Management, Safety
reporting
Urology/Erectile dysfunction III 180
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Central Laboratory, Trial supplies, Safety reporting,
Insurance, Project Management, Statistical report, Clinical Study report
Oncology/primary metastatic and /
or recurrent melanoma
Registry of
Disease
1041
Medical writing/translation (Protocol, ICON, CRF etc.), Monitoring, Central
Laboratory, Safety reporting, Project Management, Statistical report, Clinical
Study report
Endocrinology/Type
2 Diabetes Mellitus (T2DM) and/or
existing Coronary Heart Disease
(CHD)
Epidemiologi
cal study
10000
Medical writing/translation (Protocol, ICON, CRF etc.), Monitoring, Central
Laboratory, Safety reporting, Project Management, Statistical report, Clinical
Study report
Nephrology/Chronic pyelonephritis III 100
Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC
Approvals, Monitoring, Central Laboratory, Trial supplies, Safety reporting,
Insurance, Project Management, Statistical report, Clinical Study report
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts

13. Areas of activities:
Recruitment of Clinical Trial Specialists
Conducting
clinical trials
Recruitment and
outsourcing of
clinical trial
specialists
Training and
seminars in
clinical trials
HR Services in Clinical Trials
by Crocus Medical BV
• Recruitment of the CRAs,
CTAs, Study Managers etc
• Outsourcing of CRAs, CTAs etc
• Outsourcing of the complete
project teams (Crocus Medical
BV know-how!)
• Headhunting and Outplacement

14. Personnel in Clinical Trials
GCP standards in clinical trials demand operational excellence from each
employee. That is why all candidates, included to our database, were
interviewed in Crocus Medical B.V. face to face.
Adequate choice of candidates to R&D
department may increase quality and
efficiency of work.
Insufficient competence of even one
employee may extremely decrease
realization of a clinical trial.

15. Our Advantages
• Crocus Medical B.V. has a well-defined industry specialization. We
combine strong experience, proved quality and reasonable prices
for services we render.
Specialization in
clinical trials
•For over 10 years of operation, we have recruited and outsourced
over 250 clinical trial professionals, and most of them are currently
employed at the big international pharmaceutical companies. Our
data base enables us to fill vacancies promptly and efficiently.
Vast experience in
recruitment and
outsourcing
•Crocus Medical B.V. is operating in conformity with European
quality, legal and ethic standards The company’s operations are
strictly regulated by standard operating procedures (SOPs)
High standards and
quality
Introduction
About
company
Fields of
work
Completed
cases
Advantages Contacts

16. For 10 years of active work in
recruitment in clinical trials, we have
created a unique database of
professionals, who have got years of
experience in clinical trials.
All candidates, included in the
database, were interviewed in Crocus
Medical B.V. face to face.
We always get references from
previous place of employment for
each candidate.
Database of Professionals in Clinical Trials:
Experience of Work
0-1 year
45%
1-3 years
21%
4-6 years
17%
7-10
years
15%
More than
11 years
2%
Structure of our specialist database by the
experience in clinical trials

17. Database of Professionals in Clinical Trials:
Main Positions
CTA
16%
CRA
62%
Senior/Lead
CRA
15%
Project
Manager
7%
Key information from
specialists in clinical trials is
regularly renewed.
We permanently communicate
with professionals and
continuously increase our
database with new
candidates.
Structure of our specialist database by current position in
clinical trials

18. Our professionals working
in Russia and CIS countries:
 Moscow
 Saint-Petersburg
 Novosibirsk
 Samara
 Saratov
 Yekaterinburg
 Irkutsk
 Minsk (Belarus)
 Almaty, Astana (Kazakhstan)
 Erevan (Armenia)
Database of Professionals in Clinical Trials:
Geography of Recruitment
Crocus Medical BV has branch offices in Moscow (Russia),
Almaty (Kazakhstan) and Yerevan (Armenia).
We recruit specialists for work in clinical trials from
Russia and CIS countries.

19. Recruitment Process
Step 1:
Candidate shortlisting,
interview with
candidates, conducted in
a Crocus Medical BV
office
Step 2:
Interview with the
selected candidates in
the employer company
office
Step 3:
Job placement of the best
candidate

20. Personnel Recruitment Alternatives
• The successful candidate is employed through Crocus Medical B.V.
• The trilateral relations between our company, the client company
and the employee are regulated by two contracts: the employment
contract between the employee and Crocus Medical B.V. and the
contract between Crocus Medical B.V. and the Client.
• The candidate works on the client’s premises, under the direction of
the client company’s management.
• Crocus Medical B.V. assumes all financial and legal risks.
Leasing
• We select a specialist at the request of a client company in
accordance with the stated requirements and criteria.
• We receive recommendations from the candidate’s previous places
of employment.
• We select candidates based on the results of the personal interview
conducted by Crocus Medical B.V. recruiter
• Crocus Medical B.V. is the first company in Russia to use the
personnel leasing model for clinical research.
Recruiting

21. Leasing in Clinical Trials: Advantages
• Employer can avoid long and expensive procedure of personnel
recruitment, which includes searching candidates, interview and job
formalities.
• Employer can decrease administrative costs and timewasting for HR
records management, bookkeeping operations and compilation of
reports.
• Employer has got the possibility to observe work of an employee for
a long period of time and recruit without any worries about the
quality of employee’s work.
• Employer does not make a contract with the employee and can
dissolve cooperation with the employee at any time, if other was not
specified.
• Specialists are leased to the employer for execution of work, which is
specified in the contract with Crocus Medical BV.

22. Areas of activities:
Training and Seminars in Clinical Trials
Conducting
clinical trials
Recruitment and
outsourcing of
clinical trial
specialists
Training and
seminars in
clinical trials
Trainings and Seminars in
Clinical Trials by Crocus
Medical BV
• Trainings for investigators,
for novice and experienced
CRAs, for employees of
pharma-companies, unusual
trainings
• Training courses on the
client’s request (legal
regulations, bioequivalent
studies, non interventional
studies etc.)

23. Specialists, working in clinical trials,
continuously increase their professional level.
For this reason we concluded, that one of the
our main fields of work is organization of
trainings and seminars for specialists in
clinical trials.
Our connections make it possible to invite the
best lecturers from pharmaceutical industry.
23
Training of Specialists in Clinical Trials
23

24.  Without experience in clinical trials
• Basic GCP course
• Introduction to clinical trials
 With various experience in clinical trials
• Investigators
 Basic GCP course
 Career in clinical trials
• CRA, Senior CRA, Project Managers etc
 Courses and seminars, that solve current tasks
(data management, legal questions, time
management, project management and others)
 Education on request of a pharma-company
• Providing courses for investigators and personnel
Recruitment of the best
candidates for companies,
working in clinical trials
CV refreshment, maintenance of
contacts, increasing candidate
database
Job enrichment with a pharma-
company
Training and Seminars: What Do We Do?
Type of trainings for specialists with different
experience in clinical trials
For what purpose?

25. Contact Us
Introduction
About
company
Areas of
activities
Completed
cases
Advantages Contacts
Phone Numbers:
(495) 917-88-83, (495) 917-45-61
E-mail:
gcptrial@crocusmedical.com
Address:
202-6 Kazakova St., building 1, Moscow, Russia,
105064
Website:
http://www.crocusmedical.com/
In terms of cooperation and common initiatives, you can contact us
at our Moscow branch: