CLINICAL RESEARCH - Biosciencebioscience.pl/wp-content/uploads/2018/02/Bioscience_brochure.pdf ·...
Transcript of CLINICAL RESEARCH - Biosciencebioscience.pl/wp-content/uploads/2018/02/Bioscience_brochure.pdf ·...
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.
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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
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02007 2009 2011 2013 20152008 2010 2012 2014 2016
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4 www.bioscience.pl 5Contract Research Organization (CRO)
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
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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.
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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
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REACHING MANY PHYSICIANS AND PATIENTS
IN A SHORT TIME
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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.
8 www.bioscience.pl 9Contract Research Organization (CRO)
eXperience in non-interventional studies
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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
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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.
12 www.bioscience.pl 13Contract Research Organization (CRO)
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
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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
14 www.bioscience.pl 15Contract Research Organization (CRO)
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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.
16 www.bioscience.pl 17Contract Research Organization (CRO)
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
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a leader in tHe wHolesale distribution of pHarmaceuticals
18 www.bioscience.pl 19Contract Research Organization (CRO)
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
mobile: +48 604 468 500e-mail: [email protected]
agata ŁazarowiczNON-INTERVENTIONAL STUDY MANAGER
mobile: +48 608 684 500e-mail: [email protected]