Crocus medical 2015

Crocus Medical BV

(The Netherlands)

Professional CRO

10 years in Clinical Trials

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 ofthe Medical Information and Research AssistanceInstitute (MIRAI), a Dutch CRO providingservices for the pharmaceutical industry.

CROCUS Medical BV history (2)jjj

What is Crocus Medical BV?

IntroductionAbout

companyAreas of activities

Completed cases

Advantages Contacts

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CROCUS Medical BV history (2)jjj

Crocus ancestry

IntroductionAbout

company Areas of activities

AdvantagesCompleted

casesContacts

MIRAI

• By 1998 MIRAI grew to a companywith 450 employeesoperating in 13 countries including the Netherlands, Belgium, UK, Germany, Japan, France and Norway

Worldwide American CRO

• In 1998 MIRAI wassold to leading American CRO andEls van der Linden became the directorof the Benelux, Scandinavia andEastern Europe forworldwide US CRO.

Crocus Medical BV

• In 2004 Els van derLinden returned toclinical trials with Crocus Medical BV. It was established especially for operations in CIS countries.

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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 LindenFounder of Medical Information and

Research Assistance Institute (MIRAI)

Mr. Peter KunstFormer CFO of World Wide CRO

Prof. Dr.Dick KnookInstitute for Experimental Gerontology,

Rijswijk, The Netherlands

Prof. Dr.Kees KlinkhamerChief of Radiology department of

University Medical Department at

Utrecht, The Netherlands

Prof. Dr.Kees KluftPresident of international society for

Fibrinolysis and Proteolysis (ISFP),

The Netherlands

IntroductionAbout


Completed cases

Advantages Contacts

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

Areas of activities

The main activities of Crocus Medical B.V. are conducting of clinical trials, recruitment, outsourcing and training of clinical research personnel.

IntroductionAbout


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

Areas of activities: Organization and Conducting Clinical Trials

Conducting clinical trials


clinical trial specialists


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

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

Crocus Medical BV: Completed Clinical Trials

THERAPEUTIC AREA/ INDICATION PHASENR. OF

SUBJECTSSERVICES PROVIDED BY CROCUS MEDICAL BV

Hematology/transfusional iron

overload in MDS, thalassemia and

other anaemia patients.

IV 111Medical 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 Study25

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

Disease810


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

Registry76

Medical writing/translation (Protocol, ICON, CRF etc.), Monitoring, Safety

reporting, Project Management, Statistical report, Clinical Study report

IntroductionAbout


Completed cases

Advantages Contacts

Crocus Medical BV: Completed Clinical Trials



Hematology/Diagnosis of CMLRegistry of

Disease6000


Approvals, Monitoring, Safety reporting, Project Management, Statistical

report, Clinical Study report

Endocrinology /Children, adolescents

and young adults with type-1

diabetes mellitus

Registry of

Disease500




Oncology/Metastatic hormone

refractory Prostate cancer patients

Product

Registry211




Oncology/Breast CancerProduct

Registry198




IntroductionAbout


Completed cases

Advantages Contacts

Crocus Medical BV: Completed clinical trials

THERAPEUTIC AREA/

INDICATIONPHASE

NR. OF


Gastroenterology/H. pylori-

associated diseases

Product

Registry3251




Endocrinology/International

Diabetes Management Practices

Study-II

Registry of

Disease1200




Nephrology/Mineral and bone

disorders in Chronic Kidney

Disease (CKD) stage 4, 5 and 5D

Registry of

Disease50

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

Disease200




Hepatology/ Liver conditions

(chronic viral hepatitis, hepatic

staetosis, hepatic disease

related to diabetes or obesity)

Product

Registry1500

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

IntroductionAbout


Completed cases

Advantages Contacts

Crocus Medical BV: Completed clinical trials



Gynaecology/Climacteric

Syndrome in Menopause Women

Registry of

Disease289 Statistical report, Clinical Study report

Endocrinology /Diabetes Mellitus

Type 2 in Adult Population

Registry of

Disease1000

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 180Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC



Oncology/primary metastatic and /

or recurrent melanoma

Registry of

Disease1041

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 study10000

Medical writing/translation (Protocol, ICON, CRF etc.), Monitoring, Central

Laboratory, Safety reporting, Project Management, Statistical report, Clinical

Study report

Nephrology/Chronic pyelonephritis III 100Medical writing/translation (Protocol, ICON, CRF etc.), Regulatory and EC



IntroductionAbout


Completed cases

Advantages Contacts

Areas of activities: Recruitment of Clinical Trial Specialists





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

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.

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

IntroductionAbout

companyFields of

workCompleted

casesAdvantages Contacts

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 year45%

1-3 years

21%

4-6 years17%

7-10 years

15%

More than 11 years

2%

Structure of our specialist database by the

experience in clinical trials

Database of Professionals in Clinical Trials:

Main Positions

CTA

16%

CRA62%

Senior/Lead

CRA15%

Project

Manager7%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

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.

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

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

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.

Areas of activities: 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.)

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.

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Training of Specialists in Clinical Trials

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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?

Contact Us

IntroductionAbout


Completed cases

Advantages Contacts

Phone Numbers:(495) 917-88-83, (495) 917-45-61

E-mail:[email protected]

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:

Crocus medical 2015

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