WE ARETHE LIDER€¦ · KO-MED Centra Kliniczne is the le-ader in the field of clinical trials in Poland. It operates mainly in pu-blic health care units, institutes and clinical

W E A R E T H E L I D E R

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 .

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

• 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

• 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


• 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

• Vascular surgery

• Metabol ic d iseases

• Internal d iseases

• Dermatology

• Diabetology

• Endocr inology

• Obstetr ics-gynecology

• Cardiology

• Neurology


LUBLIN


• Dermatology

• Diabetology


• 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


• Dermatology

• Diabetology


• Gynecology

• Cardiology

• Neurology

• Rheumatology

• Urology

LUBLIN

Military Clinical Hospital SPZOZStudy Site

23, Aleje Racławickie 20-049 Lublin

+48 533 330 941

• 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


• Rheumatology

• Urology

LUBLIN

LuxmedStudy Site

11, Królewska Street 20-109 Lublin

+48 607 817 050


• Dermatology

• Diabetology



• Cardiology

• Neurology

• Pulmonology

• Gynecology

• Rheumatology

• Internal Diseases

• Dermatology

• Diabetology


• Cardiology

• ENT

• Nephrology

• Neurology

• Pulmonology

• Urology

• Rheumatology

• General surgery

• Traumatic and Or thopedic Surgery


• Ger iatr ics

• ENT

• Nephrology

• Neurology (Strokes)

• Or thopedics

• Obstetr ics - Gynecology

• Urology

• Diabetology


• Cardiology


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

1818 STUDY SITES BY 2022

2018 20202019201720162014-152013 2022

3

4

6

8

9

11

12

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

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

Q U A L I T Y C O U N T S

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.

CERTIFICATES

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

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

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

KO-MED Centra Kliniczne Sp. z o.o.

START-UP

[email protected]

+ 48 609 409 803

W W W . K O M E D - C K . P L

Documents

WE ARETHE LIDER€¦ · KO-MED Centra Kliniczne is the le-ader in the field of clinical trials in Poland. It operates mainly in pu-blic health care units, institutes and clinical