we arethe lider€¦ · ko-med centra kliniczne is the le-ader in the field of clinical trials in...
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W E A R E T H E L I D E R
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W E A R E T H E L I D E R
KO-MED Centra Kliniczne is the le-ader in the f ield of cl inical tr ials in Poland. It operates mainly in pu-blic health care units, institutes and cl inical hospitals.
KO-MED’s study sites are located in Warsaw, Lublin, Zamość, Biała Podlaska, Staszow and Puławy.
A special ized organizat ional struc-ture which includes exper ienced coordinators , medical assistants , data administrators as wel l as nurses and laboratory workers is in charge of management , admi-nistrat ion and medical suppor t .
KO-MED Centra Kl in iczne has repeatedly been granted status of „TOP RECRUITER” , and monito-r ing and audits demonstrate the highest qual i ty in running cl in ical t r ia ls .
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KO-MED Centra Kl iniczne is an or-ganizat ion special iz ing in cl in ical t r ia ls management. In order to get opt imal terms of cooperat ion with sponsors KO-MED Cl inical Centers has launched a START-UP depar t -ment , which is responsible for ob-taining projects for the ent i re ne-twork.
START-UP proceeds with these offers unt i l they are sent for execu-t ion (signing the contract) and ope-rat ional ises the research project to be conducted in a study site.
START-UP
• Effect ive communicat ion: one point of contact
• Shor t contract negot iat ion t ime (30 days)
• Shor t response t ime to feasibi l i ty (1-3 days)
• Managing communicat ion with • Invest igators• Document management
for / f rom Invest igators
• Suppor t in assessing the pro-ject ’s feasibi l i ty in Poland (pre-feasibi l i ty)
• Processing an inquiry for each study s i te in the network
• Swift s igning of a conf ident ia l i ty agreement (CDA) up to 2 days
• Responses from the Invest igator / Study Site to feasibi l i ty qu-est ionnaires
• Handl ing documents for pre-stu-dy and in i t iat ion v is i ts
• Central management of a l l t r ia l and team documentat ion (CVs, equipment cer t i f icates, contracts with subcontractors , etc. )
• Smooth contract ing and budget ing
INNOVATION IN THE START-UP PROCESS
ONE POINT OF CONTACT
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• Information on the potent ia l of Invest igators in the Study Si tes (PI / doctors / exper ience)
• Information about potent ia l and resources of the Study Sites
• Just i f icat ion in case of re ject ing a tr ia l offer
• Bundle pr ic ing - assessment of t r ia l prof i tabi l i ty in re lat ion to the total prof i tabi l i ty of coope-rat ion (conduct ing less prof i ta-ble t r ia ls)
• Conduct ing phase I to IV tr ia ls in a l l indicat ions
• Access to extensive pat ient databases, including those of hospita ls and inst i tutes
OBLIGATIONS TO SPO/CRO
RESEARCH PROJECT MANAGEMENT
Managerial Repor t ing to Sponsors and CROs
Multi level Recruitment System
Quality Management System
BUDGET AND SCHEDULE
CONTROL
RECRUITMENT CONTROL
CLINICAL TRIALS
QUALITY CONTROL
Study Coordinators
Recruitment Managers
Site Management
System
Patient Profi l ing System
Patient Recruitment
Managers
RAPORT RAPORT
RAPORT
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W A R S A W
B I A Ł A P O D L A S K A
Z A M O Ś Ć
L U B L I N
S T A S Z Ó W
P U Ł A W Y
STUDY SITES OF KO-MED CENTRA KLINICZNE
W A R S A W | L U B L I N | Z A M O Ś Ć | B I A Ł A P O D L A S K A | S T A S Z Ó W | P U Ł A W Y
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• Neurology
• Psychiatry
• Alergology
• General Surgery
• Internal Diseases
• Diabetology
• Gynecology and Obstetr ics
• Hematology
• Cardiology
• Oncology
• Or thopedics
• Otolaryngology
• Pulmonology
• Rehabi l i tat ion
• Urology
• Endocr inology
BIAŁA PODLASKA
Institute of Psychiatry and Neurology in Warsaw Medical Research Center
9, Sobieskiego Street 02-957 Warsaw
+48 609 409 803
Regional Specialist HospitalStudy Site
57-65, Terebelska Street 21-500 Biała Podlaska
+48 83 306 77 00, +48 603 314 074
• Ger iatr ics
• Pain Management
• Neuroor thopedics and Neurology
• Or thopedics
• Osteoporosis
• Pulmonology
• Rehabi l i tat ion
• Cardiological Rehabi l i tat ion
• Rheumatology
• Pediatr ic Rheumatology
• Developmental Rheumatology
• Rheumaor topedy
• Systemic connect ive t issue diseases
• Gastroenterology
WARSAW WARSAW
National Institute of Geriatrics, Rheumatology and Rehabilitation,Medical Research Center
1, Spartanska Street, room 210, second floor, 02-637 Warsaw
+48 533 330 824
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• Vascular surgery
• Metabol ic d iseases
• Internal d iseases
• Dermatology
• Diabetology
• Endocr inology
• Obstetr ics-gynecology
• Cardiology
• Neurology
• Rehabi l i tat ion
LUBLIN
• Internal d iseases
• Dermatology
• Diabetology
• Gastroenterology
• Gynecology
• Cl in ical immunology
• Cardiology
• Neurology
• Oncology
• Or thopedics
• Pulmonology
• Rheumatology
LUBLIN
Institute of Rural MedicineStudy Site
2, Jaczewskiego Street 20-090 Lublin
+48 500 029 749
Private Hospital and Outpatient Clinics Żagiel Med
21, Tetmajera Street 20-362 Lublin
+48 81 440 24 74
• General surgery
• Or thopedic trauma surgery
• Internal d iseases
• Dermatology
• Diabetology
• Gastroenterology
• Gynecology
• Cardiology
• Neurology
• Rheumatology
• Urology
LUBLIN
Military Clinical Hospital SPZOZStudy Site
23, Aleje Racławickie 20-049 Lublin
+48 533 330 941
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• Al lergology
• Pediatr ic a l lergology
• Bar iatr ics ( t reatment of obesity)
• Vascular surgery
• General surgery
• Dermatology
• Diabetology
• Diet i t ian
• Endocr inology
• Gynecology
• Gynecology-endocr inology
• Hematology
• Cardiology
• Pediatr ic cardiology
• ENT
• Pediatr ic ENT
• Speech therapy
• Aesthet ic medicine
• Nephrology
• Pediatr ic nephrology
• Neurology
• Pediatr ic neurology
• Pediatr ics
• Proctologist
• Pulmonology
• Pediatr ic pulmonology
• Rehabi l i tat ion
• Rheumatology
• Urology
LUBLIN
LuxmedStudy Site
11, Królewska Street 20-109 Lublin
+48 607 817 050
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• Internal d iseases
• Dermatology
• Diabetology
• Gastroenterology
• Cl in ical immunology
• Cardiology
• Neurology
• Pulmonology
• Gynecology
• Rheumatology
• Internal Diseases
• Dermatology
• Diabetology
• Gastroenterology
• Cardiology
• ENT
• Nephrology
• Neurology
• Pulmonology
• Urology
• Rheumatology
• General surgery
• Traumatic and Or thopedic Surgery
• Internal d iseases
• Ger iatr ics
• ENT
• Nephrology
• Neurology (Strokes)
• Or thopedics
• Obstetr ics - Gynecology
• Urology
• Diabetology
• Gastroenterology
• Cardiology
• Cl in ical immunology
PUŁAWY ZAMOSCSTASZOW
KO-MED’s Centra Kliniczne Study Site
Non-public Hospital in ZamośćStudy Site
Independent Public Hospital and Outpatient ClinicStudy Site
78, 11 Listopada Street 28-200 Staszów
+48 15 864 12 34, +48 533 330 827
34, Sieroszewskiego Street 24-100 Puławy
+48 81 888 63 33, +48 660 241 384
1, Peowiaków Street 22-400 Zamość
+48 84 627 88 87, +48 537 255 100
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1818 STUDY SITES BY 2022
2018 20202019201720162014-152013 2022
3
4
6
8
9
11
12
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NUMBER OF PATIENTS VS NUMBER OF TRIALS IN SELECTED DOMAINS BETWEEN 2018-2019
NUMBER OF PATIENTS Screenings in 2018-2019
NUMBER OF PROJECTS in 2018-2019
IMMUNOLOGY (VACCINE) 2
3402 !!!>
NEUROLOGY (HEART FAILURE) 2
210
DIABETOLOGY 2388
INTERNAL DISEASES (LIPID METABOLISM DISORDER)
1522
NEUROLOGY185
3
GYNECOLOGY83
3
RHEUMATOLOGY201
3
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KO-MED’s Centra Kl in iczne operat io-nal model is an advanced informa-t ion system of CTMS class which enables us to implement effect ive planning and supervis ing of c l in ical t r ia ls including costs , resources, staff ’s schedules, pat ients ’ v is i ts schedules and communicat ion ma-nagement - work standardizat ion, information f low and the repor t ing standard.
Thanks to the methodology of process management , indiv idual SMARTrials ® modules correspond to al l stages of running a c l in ical t r ia l , f rom an offer unt i l c losing and bi l l ing the study.
• 12 lead ECGs• Fr idges (b/t +2°C and -10°C) and
freezers (b/t -30°C and -86°C) with a phone alarm system in case of temperature change and maintaining temperature up to 3 days dur ing power cuts)
• Laboratory centr i fuges with cool ing systems
• Weights with height meter• Blood pressure monitors with
dif ferent cuff s izes
• Ultrasound machine with head for echocardiographic , vascular and abdominal examinat ions
• Excercise test equipment ( t readmil l , b icycle)
• RR and ECG Holter monitors• Resuscitat ion equipment
(def ibr i l lator, ant i -shock k i t )
• Infusion pumps• Hospital izat ion opt ion – bed
monitor ing system
• CT scan• Magnet ic resonance
• Alarm and f i re a larm systems• 24-hour monitor ing and secur i ty
protect ion
• Safe (eg. For INDs code cards)• Access control system• Electronic code card locks• Cabinets , f r idges, f reezers
with access control
• Doctor ’s off ices• Treatment rooms• Diagnost ic rooms• Dedicated CRA room• Medical archives
INFRASTRUCTURE INFORMATION SYSTEM OF CTMS CLASS
EQUIPMENT
RESOURCES AND TRIAL MANAGEMENT SYSTEM
SAFETY & SECURITY
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Q U A L I T Y C O U N T S
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Q U A L I T Y C O U N T S
KO-MED Centra Kl iniczne is a ne-twork of modern and thr iv ing Stu-dy Sites that receive dozens of pa-t ients every day.
Our mission is to run cl in ical t r ia ls that give pat ients a chance of reco-very and contr ibute to the develop-ment of medicine.
We have been operat ing for 20 years , and have conducted hun-dreds of c l in ical t r ia ls .
KO-MED Centra Kl in iczne is a gu-arantee of h igh qual i ty, eff ic iency and safety of c l in ical t r ia ls .
Pat ients ’ wel l being is a lways our pr ior i ty. Study methods used in our s i tes are compl iant with medical , legal , ethical and scient i f ic g lobal standards.
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CERTIFICATES
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QUALITY IN KO-MED CENTRA KLINICZNE
• The range of SOPs that includes al l stages re lated to c l in ical t r ia ls f rom pre-feasibi l i ty to archiv ing
• Creat ing new procedures or im-proving exist ing ones in order to sat isfy needs and require-ments of CRO and SMO and bui ld ing competi t ive advantage
• The concept of qual i ty manage-ment focused on meet ing the needs and expectat ions of CRO / SMO
• Regular t ra in ing of invest iga-t ing teams in the f ie ld of SOP, involvement of a l l employees in implementing the company ’s qual i ty strategy and cont inuous improvement
• Implementing the exper ience of indiv idual Study Sites throughout the ent i re KO-MED Cl in ical Centers network
• Proact ive acquis i t ion of informa-t ion on running the same cl in ical t r ia l in other Study Sites al l over the world in order to ident i fy areas requir ing special attent ion
• Qual i ty Manager in the team• Monitor ing day-to-day t imel iness
of input data gained in the cour-se of running a c l in ical t r ia l in the SMARTrials ® internal e lectronic system
• Dai ly repor t ing of Si te managers to the Qual i ty Manager and Ope- rat ions Director concerning conduct ing the tr ia l in accor- dance with the requirements
• Central ized analysis of a l l fo l low--ups from monitor ing v is i ts in order to standardize the qual i -ty of running tr ia ls in a l l Study Sites , double control of qual i ty and maintaining standards
• Annual stat ionary tra in ing cour-ses organized by KO-MED Centra Kl in iczne for invest igat ing teams
• On- l ine tra in ing• Ver i f icat ion of the val id i ty
of the invest igat ing team cer t i f icates
• Analysis of CRO and SMO expec-tat ions as wel l as observat ion of the market and i ts changing requirements
• Per iodic internal audits ident i fy-ing possible threats
• Processes carr ied out with a do-uble-check system - minimizing the r isk of human error
• Regular t ra in ing in qual i ty and procedures, t ra in ing diar ies for new employees
• Over 25 Sponsor Audits• 1 URPL inspect ion• 1 FDA audit• 0 Major f indings• 0 Cr i t ical f indings
INNOVATION IN PROCESSES RELATED TO QUALITY
GCP AND PROACTIVE ACTIONS RELATED TO QUALITY
RISK MANAGEMENT, AUDITS AND INSPECTIONS
SUPERVISION OF QUALITY
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14000
PATIENT RECRUITMENT
UNIQUE PATIENT RECRUITMENT DEPARTMENT
A qual i f ied team
of Pat ient Recruitment Managers operat ing in the f ie ld , responsible
for gaining pat ients
REPEATEDLY GRANTED STATUS OF TOP RECRUITER
MARKETING DEPARTMENT DEDICATED TO SUPPORT
RECRUITMENT
Original system of informing pat ients about avai lable t r ia ls
SHORT TIME FOR THE PATIENT TO JOIN
THE TRIAL
In most t r ia ls the f i rst pat ient
jo ins the tr ia l within 2-3 days
NUMBER OF PATIENTS IN TRIALS BY 2022
2014
2015
2016
2017
2018
2019
2021
2020
2022 14 000
11 500
9 100
6 350
4 250
2 200
1 500
1 110
530
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14000
EXAMPLE OF RECRUITMENT SUCCESS IN A POPULATION RESEARCH
62%
27%
OUR SHARE OF RECRUITMENT IN POLAND
SEASON 1+2
12524PATIENTS GLOBALLY
5508PATIENTS IN POLAND
3402PATIENTS
IN KO-MED CENTRA KLINICZNE
OUR SHARE IN GLOBAL RECRUITMENT
SEASON 1+2
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KO-MED Centra Kliniczne Sp. z o.o.
START-UP
startup@komed-ck.pl
+ 48 609 409 803
W W W . K O M E D - C K . P L
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