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