Contact us

GERMANY
Marktstrasse 5, Frankfurt / Main, Germany, D-60388

RUSSIA
Karamyshevskaya nab. 44, Moscow, Russia, 123423



Give us a call, and our representative will be glad to answer your questions!

Oleg Baykov
Business Development

Oleg.baykov@biocardcro.com

+44 2071935212

+49 6109386383

+7 499 199 0833

SKYPE:biocardcro

Last news

Outsourcing in Clinical Trials Europe 2011 Conference - Tuesday 10 – Wednesday 11 May, 2011.

 

Analysing expert outsourcing strategies on a case study-basis to simplify decision-making and mitigate the risk of sponsor-vendor mismatching.

Boasting unparalleled speaker quality and a unique approach to the way conferences are traditionally run, Outsourcing in Clinical Trials delivers what it promises: cutting-edge information intelligence, controversial debates and extensive networking opportunities.

Outsourcing and Clinical Operations professionals will find a programme peppered with case studies and exclusive topics that set Outsourcing in Clinical Trials clearly apart from other European outsourcing conferences, with the view to establish the conference as the top industry event in Europe.

 

History

- 1988 year of creation of Biocard, the first foreign trade company in the system of Soviet Russia’s healthcare.

- In 1989 Biocard managed the first in the Soviet Republic international clinical trial. In fact it received monopoly right from the Ministry of Health to undertake such studies in Russia.

- In 1990 this thriving and rapidly developing business was taken by the company’s management private, which led to creation of two entities: MPC Mirgom and MPC Pharma, responsible for clinical trials and logistical support of clinical trials respectively.

- In 1993 MPC Mirgom opened an official representative office in Europe (Frankfurt/Main, Germany).

- In 2002 Biocard’s team received a legal right to use officially its historic and original name BIOCARD.

- In 2006 logistical line of our services was reorganized into Biocard Logistics.

Geography

We can conduct clinical trials in:

  • Russia
  • Ukraine
  • Kazakhstan
  • Belarus
  • Armenia
  • Latvia
  • Lithuania
  • Estonia
  • Slovakia
  • Czech Republic
  • Italy
  • Spain
  • Portugal
  • France
  • Germany


According to the design of the study, drug, marketing and clinical requirements we can offer patient recruitment strategy to match your exact needs, making optimal tradeoff between slower and faster recruiting countries.

Our Advantage

Why work with us?

Talking from 20 years of industry specific experience we can tell that the main cornerstones of CRO business are: SPEED, QUALITY and PRICE. However, we also pay very close attention to our clientele MARKETING and FDA/EMEA regulation needs.


Biocard can recruit patients in record time and satisfy strict inclusion criteria just about effortlessly in Eastern European countries due to sheer size of population, very high percentage of treatment naive patients and relative ease of regulation. However, we do not only concentrate on Eastern Europe, we work in close collaboration with our partners to identify the best geographic targets to make further data analysis, marketing and regulative efforts as simple as possible without incurring unbearable overheads.


Biocard has built up a network of more than 2,500 investigative sites guaranteeing that only sites with the highest relevant experience and motivated personnel are chosen to participate.


Biocard’s commitment to quality. Just to give you raw figures:
- 100% of monitoring visits carried out on schedule
- 97% of reports on monitoring visits sent out within a 5 day period
- 1 query per 100 CRF pages.

Management

Dr. Natalia Baykova (CEO)
Senior Director Clinical Operations

Mikhail Gotovtsev
Senior Director Finance

Frederic Wurster
Managing Director Europe

Oleg Baykov
Senior Director Business Development & Administration


Nadya Rizvanova
Director Clinical Operations

Kristine Amirkhanyan
Director Clinical Operations

Team

Why choosing Biocard's team?

We have a team of Project Leaders.

The team of medical proffesionals:
- all of our team members worked as practitioners in major medical establishments
- all have experience in conducting international trials.

Close peer-to-peer relationships with investigators.

Expertise and credibility in conducting clinical trials.

The most important asset of our business is people. We have long standing relationships with most of our employess, which we cherish and very proud of. To date our average annual labour turnover stays below 5%.

Testimonials

“I am an investor in a Biotech company conducting a phase 2 trial in …. . We initially were modest in our request for patients through BioCard, but their excellent performance in recruitment and management of drop outs was outstanding and we eventually doubled the allocation of patients to BioCard. I met personally with the staff and found them enthusiastic and experienced. Together we visited 2 trial centers, reviewed the staff's experience, and evaluated the status of the patients. I was very impressed with the quality of the centers and their follow up. BioCard deserves the credit for establishing the relationships and making certain the centers performed. The result is they contributed more cases, all high quality, and were ahead of time in their delivery. I was more than satisfied and plan to do more trials with BioCard in other therapeutic areas. I fully support them and believe they will outperform any reasonable expectations”.

Sincerely,
PhD. Partner and former CEO




"I would like to offer my congratulations and thanks to you, the team at Biocard and your CRAs, for helping us to achieve our target enrolment for this study on time. Although you came into the study at a very late stage, I have been highly impressed by the priority you gave to this project and the speed with which you setup the sites and enrolled patients.

My thanks again and best wishes"!
Director, Clinical Operations




“Dear colleagues,

Thank you so much for your good and fast response to XYZ's request to collect additional data on the survival status of the patients in study XXX.
XYZ received an unbelievable 100% feedback on the survival status of the patients, showing that the team kept a wonderful relationship with the sites.
Since words cannot express how grateful XYZ is, neither how important the success of this additional effort is to the success of the study, please accept as a small token the little gift you find with this letter.
Your ongoing support over the years has made the study a success…
…It is with regret that the team will now dissemble and we will be given new responsibilities. Nevertheless, it is a small world, so good contacts will remain.
Thanks for your limitless time and energy…”.

Corporate Responsibility

Support

CALL US: +7 499 199 2680


EMAIL: info@biocardcro.com


Or use one of the following INSTANT MESSENGERS:
ICQ: 384481515
SKYPE:biocardcro

Project Management

In order to ensuring that all the necessary steps of a clinical trial are to run smoothly, we divide the process into three main stages:

Setup:
- Feasibility studies; choice of site
- Translation, Insurance, Labelling
- Statutory submissions (Authorities and Ethics Committees)
- Importing products and customs clearance.

Study Conduct:
- Organising and running meetings with investigators
- Monitoring (paper and eDC) and managing sites
- Project management
- Pharmacovigilance
- Centralised warehousing of products and local distribution

Closing:
- Closing centres
- Disposing of products.


At Biocard we also define lines of responsibility of our project leaders:
- Identifying, selecting and recruiting investigators
- Collecting and reviewing statutory documents
- Negotiating budgets and contracts with investigators
- Supervising monitoring activities
- Reviewing and approving reports on monitoring visits.


And doing everything to provide our partner/sponsor companies with access to the following information:
- Patient recruitment status (weekly and monthly)
- Document collection from sites
- Monitoring visits schedule
- Number of CRF Pages
- Number and status of DCFs
- Personalised reports on request.

Monitoring

Our clinical trial services can be customized to our clients needs for each particular project in question.

Here is what we can offer to you in terms of clinical monitoring:

- Evaluation visits

- Initiation visit

- Periodic visits

- In-house monitoring

- Adverse event reporting

- Termination visits

- Electronic data capture.

Regulatory

Biocard Research has a long history of cooperating with Regulatory Authorities.

We can propose to our clients:
- Local Regulatory expertise
- Close relationship with local Regulatory Authorities
- Best understanding of local practices and procedures
- Local language communication
- Strategic regulatory advice/consultancy throughout project life.

Thanks to many years of cooperation with Regulatory Authorities and Ethics Committees, we are can recruit our first patient within a maximum 3 months in Eastern countries following receipt of all the necessary documents or within 4 to 5 months in Western countries.

Examples of time taken for approvals in different countries:
Psychiatric study in Eastern Europe/Russia:
- 04 April - Submission
- 25 April - Ethics Committee Approval
- 10 May - Russian Ministry of Health Approval
- 25 May - 1st patient recruited.

Rheumatology study in Western Europe/Spain:
- 03 January - Submission
- 17 March - Ethics Committee Approval
- 28 March - Health Authority Approval
- 30 April - 1st patient recruited.

Data Management and Statistics

Here is the list of services we can offer:
- CRF and Protocol Design/Tracking
- Data Reports Generation
- Data Management and Validation Plan Creation
- Metric Reports Generation
- Statistical Analysis Plan Creation
- Database Design (paper), including EDC Screen Set-up
- Regulatory Submission
- Statistical Analysis Per Protocol
- Discrepancy Resolution
- Edit Check Programming using SQL and SAS
- Data Entry and Verification Data Review/Query Generation
- Final Trial Reporting
& etc.

Working on a project, our statisticians see each study through from protocol and CRF design to statistical report. With backgrounds in industry and academia our statistical team has extensive experience in all phases of clinical trials and many therapeutic areas.

Medical Writing

Medical writing is a detailed critical document that ensures complete integrity of the report with confidence that it accurately represents what was done, and why it was done.

Taking an objective and analytical approach to the whole study, not just the data, puts the outcome in context and anticipates issues that regulators may address at a later stage.

All our reports follow ICH guidelines. In our work we are happy to use sponsors template, or to develop one uniquely for the study in question.

We are fully aware that the report is the final product and must be both on time and accurate – there is no margin mistakes or delays.

Support Services

SET-UP AND CONDUCT OF INVESTIGATOR MEETINGS.


INSURANCE SERVICES. Finding the most suitable and least expensive insurance policy.


TRANSLATION SERVICES. We are able to provide high-quality translation of: protocol, Investigator Drug Brochures, CRF Patient Information & ICF, Patient Alert Cards, Patient diaries, patient questionnaires, Medication labels, Manuals, training materials and other visual aids. Certification of translation is used for all translated documents.

Pharmacovigilance

Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines [Source: The Importance of Pharmacovigilance, WHO 2002].

Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications.

At Biocard our two main objectives are to:
- identify new information about hazards associated with medicines and
- to prevent harm to patients or adverse drug reactions, ADR’s.

When we conduct a study, we look at several factors:
arrows_biocard_1

One of the main dangers explaining growing importance of pharmacovigilance is an opinion that at times patient samples used for studies can prove insufficient to uncover all potential ADR’s. That’s why at post marketing stage we suggest to our clients data mining and case report investigation techniques to try to identify new relationships between drugs and ADR’s.

Cardiology

“Biocard Research”has performed studies in
the following indications:

AMI
CHF
Arrhythmia
Hypertension
IHD
Pulmonary embolism
Stentimplantation
Hyperlipidemia.

We have about 100 cardiology clinics in our database.

Recent experience in cardiology - 2 studies with 535 patients recruited.

CNS

Biocard Research has performed studies in the following indications:


Cerebral vascular disease

Chronic Insomnia

Clinically Isolated Syndrome of Multiple Sclerosis

Excessive Sleepiness Associated With Narcolepsy

Multiple Sclerosis

Narcolepsy

Primary Insomnia

Relapsing Remitting Multiple Sclerosis.


We have almost 40 neurology clinics in our database.

Recent experience in CNS - 7 studies with 266 patients recruited.

Endocrinology

Recent experience in endocrinology - 1 study with 43 patients recruited.

Infectious Diseases

Recent experience in infectious diseases - 3 studies with 230 patients recruited.

Oncology

Over the last 20 years, Biocard has built a strong therapeutic experience and knowledge in the area of oncology diseases:

 

 

CLL: Chronic Lymphocytic Leukemia

NHL: Non-Hodgkin's Lymphoma

CRC: Colorectal Cancer

HCC: Hepatocellular Carcinoma

NSCLC: Non-Small Cell Lung Cancer

RCC: Renal Cell Carcinoma

Anaplastic Thyroid Cancer

Antiemetic Treatment during Chemotherapy

Biliary Tumor

Ovarian Cancer 

Gastric Cancer

Pancreatic Cancer

Breast Cancer

Prostate Cancer

Melanoma

Head and Neck cancer

Multiple Myeloma

Non Hodgkin's

Pancreatic

 

 

 


We have provided a range of services for trials within this therapeutic field and have personnel who have experience in managing these studies. Over the years Biocard covered numerous oncology areas for our clients and assessed over 1500 patients across 170 sites.

Our experience in this field has allowed us to build strong relationships with a large network of investigators, including key opinion leaders. It also provided us with the opportunity to acquire an in-depth knowledge of country-specific demographics, medical practices and ethical issues specific to those indications.

Staff Experience:
Biocard`s expertise is derived from a core staff of professionals with diverse experience, obtained in clinical, academic and pharmaceutical industry careers prior to joining the company, in addition to experience gained working on oncology projects for Biocard. Our cumulative oncology project management, industry and medical experience boasts more than 52 years.  

To add more Biocard's team just completed two NSCLC studies, therefore we are in a unique position to offer you to roll over a highly dynamic and motivated team - that has in-depth knowledge of oncology and is well versed in the challenges of oncology trials.


Recent experience in oncology - 9 studies with 323 patients recruited.

Contact Information

GERMANY
Marktstrasse 5, Frankfurt / Main, Germany, D-60388

RUSSIA
Karamyshevskaya nab. 44, Moscow, Russia, 123423

[adress at google maps]


Give us a call, and our representative will be glad to answer your questions!

Oleg Baykov
Business Development

Oleg.baykov@biocardcro.com

+49 610 938 63 83

+7 499 346 35 88

SKYPE:biocardcro

Request Information

Oleg Baykov
Business Development

Oleg.baykov@biocardcro.com

Job Opportunities

We are sorry to inform you but in the moment we are not actively searching for new candidates.


However, please feel free to send us your CVs for future references:
hr@biocardcro.com

Logistical Support

Biocard is ready to offer distribution services for whole cycle of Clinical Trial in Russia starting with importation of any clinical materials and ending with its destruction or exportation.

Here is the list of services we provide:
- Importation and Customs Clearance
- Study Materials Receiving and Checking

- Working with a cold chain
- Storage of Study Materials
- Drug Re-Labelling
- Study Materials Distribution
- Recall and return
- Destruction
- Exportation

Biocard Research owns state-of-the-art drug storage facilities:
- Company’s own drug storage facilities, separate and secure storage areas equipped with temperature and humidity gauges and computer control.
- Compliance with all temperature requirements: storage at room temperature (+18 -+25 C), in refrigerators (+2 -+8 C) and deep freezers (-20 C), including storage at -80 C.
- Company’s own staff (pharmacist) to manage storage, distribution & drug accountability.
- Monitored Access and top class security system.


What we want you to see:
Highly qualified personnel with big experience and deep knowledge in the field of Clinical Trials Logistics.

First-line supervision, internal procedures, no lead times or subcontracting to third parties. Also applicable to laboratory supplies (documents, kits, diagnostic equipment).

Effective Quality Assurance System confirmed by International Standard ISO 9001:2000.

Our passion for quality and precision. This idea runs through every single aspect of our work flow, including receiving confirmations from study sites. Accurate visibility of inventory held on site and in depots is critical to supply chain management. If sites do not confirm receipt of medication, this can impact on the entire progress. Here is why at Biocard we go an extra mile. We train our employees to very carefully monitor such receipts, including reaching out to every single site over the phone or in person to confirm and carefully record receipts time, date and any additional information relevant to the project.

 

At Biocard we clearly understand that medical logistics mistakes are very costly. As professionals we do not have margin for failure as to not undermine progress of an expensive study and create delays, which can limit patients’ access to lifesaving, effective and modern treatments!


If you want to learn more about our logistics line of services, please follow the link to Biocard Logistics website.

 

 

 

Overview

R&D costs and delayed product registration is a failure to recruit patients on time. Even more so, it is estimated that 80% of clinical trials fail to recruit on time (J. King. Ten Ways to Faster and Easier Patient Recruitment. R&D Directions, April, pp 34-46, 2004). Despite numerous initiatives within the pharmaceutical industry to reduce them, product development timelines continue to fall in the 10-15 year range.

In Western Economies, the traditional market for clinical trials, pharmaceutical companies compete for the same limited pool of investigators and patients. These factors contribute to the recruitment delays and skyrocketing overheads described above.

On the other hand, emerging clinical trial countries offer access to large patient populations, the majority of which are treatment naïve; well trained and enthusiastic professionals; and to our regret a lot of rare and severe poorly treated deceases.

Biocard Research is a full service CRO with a strong record of being fast, quality recruiter. We have solid roots in Eastern Europe and specialize on coverage of Western, Central and Eastern European countries.

BIOCARD:

-  In excess of 320 successful system and site audits, including FDA. 

-  80% of studies completed recruitment ahead of schedule.

-  350 successfully completed studies.

-  Exceptional patient-per-site ratio.

 

And our crown jewel is the fact that we have over 75% repeat business!

 

 

Pulmonology

Biocard Research has performed studies in the following indications:
COPD
Asthma
Chronic bronchitis.

We have 60 pulmonology clinics in our database.

Recent experience in respiratory - 1 study with 330 patients recruited.

Psychiatry

“Biocard Research” has performed studies in
the following indications:

Agoraphobia
Epilepsy
Schizophrenia.

We have about 30 psychiatric clinics in our database.


Recent experience in psychiatry - 2 studies with 150 patients recruited.

Gynaecology

Biocard experience in the field of gynecology is well established across a broad range of therapies. We have managed in excess of 15 studies examining the therapeutic values of compounds in the treatment of:

Endometriosis

Infertility

Breast disease

Endometriosis

Contraception

Ovarian disease

Hormone replacement therapy

HRT

Endometrial hyperplasia

Menopausal symptoms

Oncology – breast, ovarian and uterine

Osteoporosis.

 

Biocard has established relationships with key gynecological centers in the regions where it operates. 

 

Orthopedy

Therapeutic experience is essential to a successful project delivery: Biocard has established relationships with key orthopedic centres.

Biocard experience in the field of orthopedy is well established. We have managed in excess of 10 studies and Biocard is well versed in the challenges of long treatment duration through the management of trials ranging from 3 to 5 years treatment length:

Osteoarthritis of the knee
Osteomyelitis
Thromboprophyalaxis after total knee replacement
Symptomatic Knee Osteoarthritis
Venous thromboembolism after total knee replacement
Leg Amputation.

 

Mission

"Clinical trial expertise in the world, which never stops changing".

Bioequivalence Studies

For local drug registration purpose and for registration in EU

  • Collaboration with most experienced local units and analytical labs (local and EU)
  • Own DB of volunteers
  • Medical writing
  • Regulatory: preparation of the submission package and close follow-up of the approval process
  • Import/Export
  • Monitoring/QC
  • Independent Audit
  • Final Report

Courier Service

Own courier service

  • Special temperature and humidity controlled vehicles
  • Experienced and trained staff 
  • Accountability at every stage of the process

Customs Clearance Services

Unmatched customs clearance performance

 

  • Importation/exportation of all kinds of study materials (drugs, lab Kits, CRF’s, ECG machines, etc.)
  • Your consulting assistant in obtaining import/export licenses
  • Customs clearance under 24 hours!