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Professionals in the clinical research field since 2001, joined
together in this company (established 2013)
Evolution to full scope of services (since 2015)
Reach out to neighboring countries and evaluation of
partnering CROs in CEE (since 2017)
Highly experienced and motivated management and
operative staff
Already achieved benchmarks to serve as value indicator for
the company team as one of the leading parters in the region
Early phase biosimilar studies (challenging and complex
designs) in the partnering phase I unit;
Effective Site selection, support and education for late phase
studies;
Recruitment and retention (both early and late phase
studies);
Coordinating point and leader in management of phase II/ III
trials in a network of small-middle-sized CROs to compete
with large CROs
CD Branch offices
CD Partners
Project Management and Medical Writing
Study Set-Up
CTAs and SAMs plus Regulatory Support and Solutions
Study Monitoring, Recruitment and Retention Solutions
Clinical Data Management
Software development of custom tools (EDC, IxRS, ePRO, etc.)
Medical Monitoring and Medical Review
Biometrics
Pharmacovigilance
Site management (all phases) and Site staff trainings
Experience in management of more than 10 phase II /III
protocols. Covering over 4 to 6 countries (up to 300 pts sample
size). Respecting and completing earlier than timelines.
Completing full service for the first biosimilar project FiM (phase
I) in Bulgaria, including CSR. 156 Healthy Volunteers enrolled in
one month. Demonstrated full biosimilarity.
One product successfully placed on market (IUD) following a
drug development plan drafted and conducted by the team.
Covering from synopsis creation through Scientific Advice and
CSR delivery. (2007-2011)
Participation and significant input in studies (phase I and III)
with one of the first biosimilar IP (trastuzumab) as part of the
large CRO team (2010 -2012)
4%
13%
11%
15%
15%
4%
7%
7%
7%
11%
2% 4%
Cardiovascular
Rheumatology
Neurology
Respiratory
Infectious diseases and Vaccines
Endocrinology
O&G
Paediatrics
Gastroenterology
Oncology
Oncohaematology
Haematology
More than 17 years of experience in full aspect of all services
provided.
12 years of management experience in phase I and II
/Healthy Volunteers and patients/, FIH/P, PoC/PoP, , BA/BE and
biosimilars clinical trials.
Management of national and international early phase
projects in various therapeutic areas, including leading full
service projects.
Management of local and multicounty phase II and III
studies, including full service projects .
14 years of Medical Writing experience with full coverage all
aspects.
Regulatory consultancy, application and communication.
Establishment of relationship with CA and EC.
Management and coordination of cross functional teams for drug
development programs.
Communication management with Sponsors, CROs, Physicians
and Regulatory Authorities.
Day-to-day oversight or performance of operational tasks related to
the conduct of phase I - IV clinical trials.
Development, maintenance of Standard Operating Procedures
(SOP) and applying Good Clinical Practices (GCP) and other
applicable regulatory guidelines in all aspects of projects.
Strict control over project milestones and best project management
practices.
More than 40 projects completed;
Phases covered: I,II, IV phase and BA/BE projects;
Services provided:
◦ Collecting, cleaning, and analyzing clinical data;
◦ Building custom applications like IWRS, EDC, DDE and
CTMS;
◦ Prepare data for regulatory submission, SDTM and ADAM
including Define.xml;
More than 30 system and project audits performed, only minor
findings;
1%
31%
4%
8%6%
24%
4%
6%
1% 1%2% 7% 5%
Vaccines
BE/BA
Paediatrics
Respiratory
HI/RI studies
Rheumatology
Dermatology
Neurology
Ophthalmology
Cardiology
Oncology
Nephrology and Dialysis
Obstetrics & Gynecology
Phase II and III studies – 20+ biosimilar protocols (large and
mid-size molecules since 2008
Phase I – FIM study in trastuzumab biosimilar (since 2010) and
a phase III trial (same IP)
Company experience in full scope service study development
and conduct – a phase I protocol biosimilar product
Located in a private hospital, 2 floors and equipped withstandard and state-of-the-art devices
36-beds Phase I, FIM,BE/ BA unit plus 4 intensive carebeds
24/7 monitoring for in-house subjects
Dedicated medical team, physician available 24/7
Reanimation and resuscitation team at days with IPadministration
Manager unit with 12+ years research experience
4 Study coordinators with 9+ and 5+ years research experience
Full therapeutic coverage of specialists - 4 Pulmonology, 3
Rheumatology (incl a KOL), 3 Neurology (incl a KOL), 2
Pharmacology, 2 Cardiology, 2 Nephrology, 1 Dermatology, 4
Orthopedic Specialists (incl a KOL), 2 Gastroenterology, 1
Ophthalmology, 1 O&G, a General Lab plus another Microbiology Lab
Specialist
4 Anesthesiology Specialists, plus 2 X-RAY/ Ultrasound Specialists
and 2 Pharmacists
6 General Practitioners
7 Study Nurses with 7+ years research experience
2 Laboratory Technicians with 6+ years research experience
Plus a developed and proven network for healthy volunteers and
patient volunteers enrolment supply
A team of motivated professionals in possession of…
Qualification and culture to meet high client expectations by
means of tailor-made approach
High respect to quality of work and timelines
Result oriented and cost driven delivery of services
...may lead to excellent results:
reduced timelines in adherence to high quality standards
prompt, precise and reliable performance
operational and financial efficiency
…based on the mixture of optimal and skillful management and
collaboration with clients