CLINICAL RESEARCH - Biosciencebioscience.pl/wp-content/uploads/2018/02/Bioscience_brochure.pdf · poland is the largest clinical trials market in cee. there are about 400-500 new

CLINICAL RESEARCH

FULL-SERVICE SOLUTION

2 www.bioscience.pl

scientificadvice

crfmedicalwriting

start-up

applicationforms

data management

biostatistics

project management

qualitymanagement

trainings

delivery drugs for clinical trials

equipment outsourcing

2 www.bioscience.pl 3Contract Research Organization (CRO)

poland is the largest clinical trials market in cee. there are about 400-500 new clinical trials registered in poland every year (458 trials were registered in 2016). more than 50% of them are phase-iii and about 30% phase ii. oncology is the most dominant field in the therapeutic areas making up more than 20% of all the trials conducted. other important fields are neurology, pulmonology, rheumatology and pediatrics.

clinical researcH in poland

project management

employeeoutsourcing

the market of clinical trials is developing quite rapidly due to the following:

O a population of 38 million provides access to a large number of patients

O a mature market and professional clinical research facilities

O well-qualified medical staff and teams experienced in the field of clinical trials

O well-organized and specialized clinical trial sites

O presence of global and local CRO companies

O many well-qualified and experienced CRAs

O high quality of data collected with attractive cost levels compared to Western or even Central Europe.

4 www.bioscience.pl

bioscience sa is a full-service contract research organization (cro) located in bydgoszcz and established in 2006. we offer clinical trial management services in poland and european countries across every phase of the clinical development process. we have successfully completed more than 90 projects in poland, germany, czech republic and spain for numerous customers including the largest pharmaceutical companies. 12 000 patients in over 800 sites.

Bioscience S.A. is divided into three departments: clinical trials, non-interventional studies and outsourcing. We have an experienced team of professionals responsible for project management, clinical monitoring, study administration and maintenance of study documents.

We have two offices: in Bydgoszcz (head office) in the North and Katowice in the South of Poland. Since 2015 Bioscience has been part of the NEUCA Group. Neuca is one of the biggest and fastest growing companies in Poland and is active in many areas of the national healthcare market.

bioscience eXperience

2006

14 000

12 000

10 000

8 000

6 000

4 000

2 000

02007 2009 2011 2013 20152008 2010 2012 2014 2016

patients

2006

900

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02007 2009 2011 2013 20152008 2010 2012 2014 2016

sites

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02007 2009 2011 2013 20152008 2010 2012 2014 2016

projects

87

831

11 959


we cooperate with pharmaceutical (mainly with big pharma) and biotechnological companies, cros, leading scientific centres and associations, including the medical university of warsaw, jagiellonian university and polish myeloma consortium.

we conduct clinical trials of all phases (i-iv) on new drugs and medical devices in the following therapeutic areas:

O ONCOLOGY

O HEMATOLOGY

O NEUROLOGY

O CARDIOLOGY

O DIABETOLOGY

O GASTROENTEROLOGY

O DERMATOLOGY

O PULMONOLOGY

O IMMUNOLOGY

O THERAPEUTIC VACCINES

O PREVENTIVE VACCINES

O RHEUMATHOLOGY

Our approach to managing the conduct of clinical trials is grounded in the ICH-GCP guidelines. High quality and good performance has been confirmed by FDA and EMA inspections, as well as by international audits.

43audits

2EMA

inspections

4FDA

inspections

3Ministry of Health

inspections

6 www.bioscience.pl

bioscience offer

we provide a wide range of services in drug and medical device development: clinical trials phase i-iv, investigator initiated trials (itt), medical device trials, non-interventional studies (nis), pediatric clinical trials. bioscience provides a range of customized services in order to meet the client’s requirements.

WE OFFER:

O Scientific Advice O Medical Writing O Study Start-up O Regulatory Affairs O Site selection (Feasibility Assessment) O Pharmacovigilance O CRF and Data Management O Biostatistics O Project management O Preparing CSR

O Clinical Monitoring by trained and experienced CRAs (RBM)

O Translation of documents O Audit and Inspection Preparation O Quality Assurance O Trainings for site team (GCP, protocol,

study procedures) O Delivery of study drugs to sites (labelling,

release by QP, packing, transport)

Depending on the client’s needs, we also provide other services, such as: organizing meetings of Investigators, renting equipment dedicated to clinical trials, patient recruitment support, development of standard operating procedures (SOP), preparation of biological sample transportation logistics, and negotiating contracts with investigators and sites.

Bioscience is a reliable partner for global and nationally operating companies requiring single service solutions such as investigational product delivery, regulatory affairs, project management or full-service solutions.

We are a partner and contributor, not just a vendor.

6 www.bioscience.pl 7

non-interventional studies

non-interventional studies are a perfect alternative in situations where there is no need to conduct a clinical trial. they provide excellent support for health service:

O they provide a large amount of data, comparable to those obtained from clinical trials, but at much lower costs

O they make it possible to evaluate medicinal product and medical device safety and efficiency in the long period of their use

O they allow for the verification of patient compliance with doctors’ recommendations

O they are source of comprehensive and reliable data for publication

it is recommended to conduct non-interventional studies in the following manner:

O involvement of authorities in particular therapeutic areas

O managed with the Declaration of Helsinki and Good Clinical Practice (GCP)

O approved by appropriate Bioethical Committees O organized and strictly monitored by specialized CRO

after over 10 years of ongoing experience, we have managed to create our own base of facilities. we have access to specialists from various therapeutic areas all over poland.

O we provide non-interventional research in many different medical fields, such as neurology, oncology, hematology, infectious diseases, diabetology and treatment of chronic pain

O over 500 researchers and over 3200 patients have participated in our research, and these figures are still increasing

M O N T H S

PA

TIE

NT

S I

NC

LU

DE

D I

N T

HE

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SE

AR

CH

01

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05 0903 07 1102 06 1004 08 12

REACHING MANY PHYSICIANS AND PATIENTS

IN A SHORT TIME

8 www.bioscience.pl

eXperience in non-interventional studieseXperience in non-interventional studies

O Results of our studies have been published as scientific articles and presented at international conferences during live speeches.

O We cooperate with the Polish Myeloma Consortium, for which we coordinate research sponsored by a Spanish company, as a part of non-interventional research.

O We have managed non-interventional studies in pharmacies throughout Poland. We obtained 2000 contacts, signed 200 agreements with pharmacists, and as a result 1300 patients participated in this study.

O We have established long-term cooperation with sponsors and, at the moment, we are performing the study with pharmacists in germany and our previous partner.


eXperience in non-interventional studies

10 www.bioscience.pl

we have developed services related to clinical trial logistics, including acquisition of medicinal products, comparators, rescue drugs and their preparation for use in clinical trials.

At the sponsor’s request, we prepare appropriate labels according to the presented design and place them on the immediate and external packages of the investigational medicinal product. Bioscience works with Qualified Persons responsible for certification and batch release of a series of investigated products in accordance with the current European Parliament Directive and GMP requirements for investigational medical products.

We guarantee storage and distribution to the centers for testing medicinal products under controlled temperature conditions as part of the order processing.

The complexity of the service provided is complemented by the return of the investigated medicinal products and their disposal by suitably qualified companies attesting the destruction process by a relevant certificate.

Label design & Label printing

Batch release

QP Services

Storing in controlled conditions

Pick and Pack

Distribution to facilities

clinical trial supplies & logistics

IMP

11Contract Research Organization (CRO)

labelingAccording to the label provided by the sponsor, we prepare, translate and make substantive verifications the labels and then print and mark them. The service includes the labeling and packaging of tested investigated medicinal product for both direct packaging and bulk packaging. The whole procedure takes place at a temperature from + 2ºC to + 8ºC and from + 15ºC to + 25ºC, subject to the requirements of the GMP compliant product.

storageWe have specialized warehouses equipped with fully upgraded technical infrastructure to ensure proper storage and control of the storage conditions of tested products, comparators and associated medicines used in clinical trials. Our facilities have validated temperature and humidity monitoring systems that allow for safe storage and repacking of products in the range from + 2ºC to + 8ºC and + 15ºC to + 25ºC. The entire storage process is supported by dedicated computer systems and is based on procedures and manufacturing instructions.

domestic and international transportAs a company belonging to the NEUCA Group, we have a specialized logistic unit that provides service in accordance with Good Distribution Practice principles. We provide timely distribution of drugs to Clinical Research Centers under controlled temperature conditions. The monitoring system takes continuous measurements in the cargo area in each of our vehicles. The staff is trained on every load and transport of medicines and medical supplies. We also transfer individual shipments in order to maintain the proper temperature conditions.

IMP


qualified person (qp) An experienced Qualified Person (QP) plays a key role in ensuring the quality of a medicinal product in the pharmaceutical industry. A QP’s responsibilities include issues such as certification, making decisions to batch release a series of medicinal products or not, product quality review, stability testing, complaints and product recall and change control. A medicinal product marketed within the EU must have marketing authorization and must be manufactured and released for marketing in accordance with GMP requirements. According to the EU pharmaceutical law, a QP is equivalent to the release of a medicinal product that meets the requirements of the current law. Bioscience works with an experienced qualified person, responsible for the certification and release of investigational medicinal products (IMPs) and reference medicines used in clinical trials.

buy comparators (reference drugs)In order to provide a full service, we offer cooperation in obtaining reference medicinal products with an optimum expiry date and required EU-wide purchase documents.

receiving and displayAs a result of clinical trials related to the manufacture of test products, Bioscience ensures the organization of returns of unused medical products and their disposal. A certificate confirming the destruction is included in the activities carried out.


The Department of Outsourcing at Bioscience S.A. is involved in the recruitment of personnel, selecting the right person with the qualifications and experience required by the customer, so that allocation to the project will be efficient. The outsourcing department also conducts negotiations and arrangements with the customer of the conditions and duration of service, equips the employee with the necessary resources, provides industry training, and ensures that the implementation of services will be top notch.

As part of the outsourcing of business processes, we provide high-quality services in:

O staff outsourcing: » Clinical Research Associates (sCRA, CRA) » Administrators and Clinical Trial Assistants » Clinical Project Managers (CPM) » Experts in the Safety of Pharmacotherapy

(Pharmacovigilance/Drug Safety) » Quality Assurance Specialist » GCP Auditors

O outsourcing of equipment for clinical trials: » Low temperature freezers » Refrigerators with freezers » Centrifuges with cooling and heating » Incubators with cooling and heating » PCB certified precision laboratory scales » Electronic thermometers » Other - as agreed with the customer

employee outsourcing in practice


Lp. Clinical Research Professionals

1 Clinical Research Associates (CRA, sCRA)

2 Administrators and Clinical Trial Assistants

3 Clinical Project Managers (CPM)

4 Experts in the Safety of Pharmacotherapy (Pharmacovigilance/Drug Safety)

5 Experts in Quality Control, GCP Auditors

Lp. Medical laboratory equipment

1 Low-temperature freezers to -86°C, Arctico, model ULTF 80

2 Refrigerated cabinets BOLARUS with a -20°C freezer, model S/SN 300 L

3 MPW-260RH centrifuges with cooling and heating

4 18 litre incubators with cooling and heating

5 PCB 1000g 0.1g certified precision laboratory scales

6 Electronic thermometers

our service



wHat stands out in tHe clinical trial market?

guarantee of eXecution

If we undertake to execute a project, we

complete it successfully and consult any

necessary modifications to the project with the

customer.

compreHen- siveness

We complete all tasks within the project depending on the customer’s needs.

timeliness

Milestones are our priorities so we deliver

data on time.

knowledge and competence

We offer an experienced and devoted team

of specialists in the preparation and

conducting of clinical research.


fleXibility

We adjust our actions to the

customer’s needs.

cost efficiency

We pay particular attention to optimizing

the costs of our services.

individual approacH

Every project is important to us

and we are always fully devoted when

executing both complex, large-scale projects, as well as those smaller and

simpler ones.

trust

Our customers often return to us with other

projects.

patient services logisticsTransport and logistics

sHaredservices centreand it centreAccounting services and Accounting IT services for the Group.

our own mediaPro-health activities

services for tHe HealtH market

managemement of our own brandsCreating and developing new pharmaceutical brands

wHolesale activities

MEDICAL OUTPATIENTCARE CLINICS:

E-COMMERCE:

INNOVATIONTEAM:

clinical trials:

TELEMEDICINE:

a leader in tHe wHolesale distribution of pHarmaceuticals


a leader in tHe wHolesale distribution of pHarmaceuticals


bioscience s.a. - contract research organization (cro) www.bioscience.pl

pratia s.a. - site management organization (smo) www.pratia.com Upon the clients request, Pratia conducts phase II-IV clinical trials (120 trials executed in 8 clinical trials centres in 2016). All clinical processes are undertaken and executed according to the latest international standards. Pratia is the biggest organization of such kind in Poland. Besides prioritizing quality and patients safety, we pay special attention to providing our clients with a beyond professional service - we deliver complex, tailored solutions.

synoptis industrial sp. z o.o. - clinical trial supply chain, packaging & logistics www.synoptisindustrial.plThe company benefit from the strength of the Neuca Group and thus is the only company to deliver complex services in the entire supply chain of pharmaceuticals delivery also in clinical trials field. The range of services includes: clinical trial logistics, warehousing and delivering to sites (PL, EU), QP services, manufacturing (label design and label printing), packaging, return, final reconciliation and certified destruction. Synoptis Industrial offer services in accordance with the Good Manufacturing and Distribution Practices.

26Years of tradition

29%Market share in the

pharmaceutical distribution market in

Poland

32%Market share in the

pharmaceutical distribution to independent pharmacies

14 000Number of pharmacies

serviced by Neuca

we have exceptional abilities derived from the company’s unique position at the intersection of many areas of the healthcare market.

clinical trials in neuca group are accomplished by three specialized in particular areas companies

beata maciejewska CLINICAL RESEARCH DIRECTOR

mobile: +48 602 146 500e-mail: [email protected]

przemysław magielskiOPERATIONS DIRECTOR

mobile: +48 661 600 661 e-mail: [email protected]

contact us

Bioscience S.A. provides a full range of services including:O Planning and execution of clinical research of new medications and medical devicesO Support in developing non-commercial researchO Supporting projects of surveillance and educational researchO Supplying medications for clinical researchO Outsourcing employees and equipment for clinical research

bioscience s.a., biznes park - deltaul. kraszewskiego 1, 85-240 bydgoszcztel. +48 52 324 10 44, fax +48 52 381 34 [email protected], www.bioscience.pl

bioscience s.a., euro centrum, park naukowo-technologicznyul. ligocka 103, 40-568 [email protected], www.bioscience.pl

amelia pietrykaOUTSOURCING MANAGER


agata ŁazarowiczNON-INTERVENTIONAL STUDY MANAGER


CLINICAL RESEARCH - Biosciencebioscience.pl/wp-content/uploads/2018/02/Bioscience_brochure.pdf · poland is the largest clinical trials market in cee. there are about 400-500 new

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