crocus medical bv

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, C linical 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



report, C linical Study report

Oncology/Breast CancerProduct

Registry198



report, C linical Study report

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


Insurance, Project Management, Statistical report, Clinical Study report

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


Insurance, Project Management, Statistical report, Clinical Study report

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

Your company becomes flexible. You work with personnel, that you really need

You work with personnel within the period that you need

Your company does not arise from labor relations specialists,

as all of them are employees of Crocus

Medical BV

The main advantages ofpersonnel leasing

Phases of clinical research

Definition of the project design, inclusion criteria, power, sample size, and so forth.

Writing the research protocol and other documents

Submitting documents to the Ministry of Health and Ethics Committee

Selection of medical centers and researchers

The launch meeting of researchers; conducting training project

Initiation centers, monitoring the quality of the visits, closure visits

Conclusion of contracts and realization of payments to doctors and medical centers

Required experts

Project manager

Data Manager

Statistician

Legal Expert

Medical writer

Startup manager

QA manager

The team of monitors

At each stage of the clinical trial need different specialists

Crocus Medical BV - a Dutch

company. We are engaged in the selection and provision of

personnel to work in clinical

trials since 2004.

In 2016 Crocus Medical BV has

received one of the first accredited by the Ministry of

Labour of the Russian Federation, which allows us to

provide personnel.

Specialization - Clinical and epidemiological studies

Experience of recruitment for over 12 years

The quality and standards of work

Crocus Medical BV: About us

What employees need

for your company?

Crocus Medical BV selects and providesa full range of specialists for work

in clinical trials I- IV phases, bioequivalence, and epidemiological

studies.

If you know the perfect candidate for your company, Crocus Medical BV

will be able to issue candidate in the lease and provide to Your company.

CRAs and CTAs

Project Managers

Specialists for registrayion

Specialists for contracts

Pharmacovillagiance specialists

Medical writers

Startup specialists

Why do you get the best specialists

in clinical trials?

Extensive experience in industry research

Crocus Medical BV selects personnel for clinical research since 2004

Crocus Medical BV has successfully passed the audit of the State Labour Inspectorate in 2012

More than 2,000 interviews

Our recruiters have spent more than two thousand interviews with people from the world of clinical trials.

Real knowledge of candidates for leasing

We personally know almost every monitor, manager or assistant, working in clinical research in the CIS countries. This allows you to locate candidates that best meets your needs.

Wide geography

Our unique database of candidates includes specialists from Russia, Kazakhstan, Belarus, Armenia, Ukraine, Georgia and Mongolia. We will pick you a specialist in any city in the country and the CIS.

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

20

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?

Contacts

Telephones:(495) 917-88-83, (495) 917-45-61

E-mail:

[email protected]

Address:105064, Москва, ул. Казакова, д.6, стр.1, оф. 202

Web-site:http://www.crocusmedical.com/

For all the issues of cooperation, you can contact our Moscow branch.

We will be happy to answer all questions.

IntroductionAbout


Completed cases

Advantages Contacts

crocus medical bv

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