Richard Leach is Vice Presidentand Head of Business Developmentfor Russian Clinical Trials Global, aregional contract researchorganisation (CRO) located in StPetersburg, supporting clinicalresearch throughout Russia, theUkraine, and Bulgaria. Prior tojoining Russian Clinical Trials, MrLeach was Director of BusinessDevelopment for PharmaNet,responsible for developingcorporate relationships with keyinternational accounts. Over his 15years in the pharmaceuticalindustry, he has had the pleasureof working with companies offeringinternational services as diverse ascentralised laboratory andelectrocardiogram (ECG) monitoringto regulatory support and projectmanagement. Prior to his positionat PharmaNet, Mr Leach heldnumerous positions with CovanceLabs, Premier Research, andQuintiles Late Stage Development.

a report by

R i c h a r d L e a c h

Vice President, Business Development, Russian Clinical Trials, LLC

Speed and Qua l i ty – There can be no Compromise

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For companies involved in clinical research, patientrecruitment and quality of data are probably the twomost discussed themes during team meetings. Forsome project managers it is their mantra – these twoelements can determine the success or failure of adevelopment programme. Though they are totallyseparate in how teams deal with each issue, they areforever tied together; speed without quality is like arace car on a roundabout, and quality without speedis like a horse-drawn carriage on the autobahn. Onewithout the other can lead to frustration andaggravation or worse, failure.

Table 1

Some of the Most Estimated

Populated Cities Population

Moscow 10,000,000

St Petersburg 4,500,000

Kiev – Ukraine 3,000,000

Novosibrisk 1,500,000

Ekaterinburg 1,500,000

Khar’kov – Ukraine 1,500,000

Sofia – Bulgaria 1,200,000

All city populations have been rounded to the nearest 100,000

Recognising the inseparable characteristics of thesetwo forces in research, many companies andproject managers have looked to establish partnersin countries where patient interest is high and themedical community is motivated and welleducated. An example of this approach is thecontinual growth of research in the EU countriesand the current trend toward development inRussia, India, South America and China. Each ofthese countries offer benefits in terms of patientaccess and professional medical care. Only Russia,however, provides access to more than 144 millionprospective patients (over 14 million in bothMoscow and St Petersburg alone), combined witha wealth of experienced investigators and astreamlined regulatory submission process.

E n r o l lm en t

Russian Clinical Trials (RCT) is a growingregional CRO located in St Petersburg Russia.

Although many of the studies they have worked oninvolve sites in St Petersburg and Moscow, theyalso work with clinical sites in other cities acrossRussia, the Ukraine and Bulgaria. The table to theleft provides population information for some ofthe most populous cities in the region. These citiesprovide their population with large, centralisedmedical institutions dedicated to specifictherapeutic areas, with motivated investigatorspracticed in clinical research. In addition, theprospective patients who are treated in thesefacilities are eager to have access to westernmedicines and medical care available throughclinical trials. The combination of a largecentralised population base, motivatedinvestigators, and eager, compliant patients hasmade this region one of the world’s fastest growingclinical research areas, providing consistentenrollment success.

Qua l i f i e d S i t e s a n d Qu a l i t y D a t a

RCT has benefited significantly, due to the increasedinterest in the area and because of their commitmentto quality and cost-effectiveness. In a world wheremany consider bigger to be better, RCT hasmaintained a flat business model, keeping overheadsto a minimum while keeping quality its number onegoal. By offering audit support for every trial andproviding upfront, in-depth feasibility information asa standard practice, they have successfully managedtheir clients’ enrollment expectations while fulfillingtheir quality obligation.

Prior to every trial, RCT performs an in-depthfeasibility study; collecting key information from thesites specific to the individual study. Informationregarding therapeutic site experience, clinical trialexperience, competitive trials, InternationalConference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticalsfor Human Use Good Clinical Practice (ICH GCP)knowledge, electronic data capture (EDC)experience, access, validation aspects of trial-specificequipment, and expected enrollment rates as theyrelate to the trial, are collected and presented to theclient during the proposal process. If during study

start-up additional sites are needed, RCT is preparedto address that need since they pre-qualify 20% moresites then are needed for the trial, allowing forflexibility and last-minute changes.

P e e r Mon i t o r i n g

The RCT process and project management modelis focused on client-specific goals with an emphasison quality. Over and above the process is theexperience and clinical knowledge of theindividual monitor. Every project manager andmonitor at RCT is a doctor that at one time oranother has treated patients and/or performed as aninvestigator. Having doctors as monitors in Russiais critical in establishing an atmosphere of trust andmutual respect. A monitor who understands theconcerns of the investigators, and can work to

address these concerns before they are verbalised,will be seen as a critical partner in the success of thesite, adding value to the programme as a whole. Inaddition, these monitors, due to their scientificbackground and experience, are better positionedto challenge CRF entries and have data correctedduring the monitoring visit, saving both time and effort.

RCT continues to grow and expand as a result ofrepeat business and word-of-mouth referrals. Theirexpertise is exceptional and their regional focus instillsconfidence within their client base. Their businessmodel was developed to keep costs under control,while still providing their clients the professionalismthey deserve and the services they need most. RCThas the experience, flexibility and focus to keep theirclients happy long into the future. ■

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Contact: Richard Leach Phone: (609) 731-2225

St. Petersburg, RussiaMoscow, Russia

Sofia, BulgariaKiev, Ukraine

Bucharest, RomaniaPrinceton, USA

The recent growth in pharmaceutical development in the Russian Federation, Bulgaria, Romania and the Ukraine has attracted the attention of drug development companies all over the world. Pharmaceutical and Biotech companies along with numerous international clinical research organizations have seen the value and have invested heavily. Everyday new offices are opening and trials are being initiated. Though this growth can be attributed to many things from the globalization of research to increasingly friendly regulatory environments one key element continues to drive interest, Patient Availability.

The Russian Federation, Bulgaria, Romania and the Ukraine represent a population in excess of 200 million people. In major cities like Moscow, St. Petersburg, Novosibirsk, Sofia, Kiev and Odessa there are numerous hospitals and scientific research centers that are highly-specialized offering hundreds of beds. Many of these centers are pathology specific and attract patients from the local area (over 70% of the population live in and around major population centers).

Global Clinical Trials, LLC (GCT) is a Regional CRO with it’s headquarters located in Princeton, NJ and offices in Russia, Bulgaria, Romania and the Ukraine performing clinical research services across Eastern Europe. GCT is experienced supporting trials across all phases of research and therapeutic areas; working with international clients from across the globe. Whether you are looking for full clinical support to include site selection, monitoring, project management, Regulatory, import/export, drug storage, and medical writing; or only interested in an individual service to address an urgent need, you can count on GCT to handle your requirements professionally and completely.

We offer a strong understanding of both local and international regulations as well as access to 1,000s of qualified sites in numerous therapeutic areas. The GCT data base identifies over 2,800 experienced sites throughout the region by indication and experience. Our pre-qualification process includes a review of ICH/GCP as well as local law for each site, to determine if additional training is required. Our monitors and project managers are all certified clinicians experienced in clinical research. Their relationship with each of their sites is strong and based on mutual respect. As an organization, GCT maintains strong ongoing relationships with the investigators and officials in the Ministry of Health. These relationships help us to develop reliable feasibilities and stay abreast of the changes in governmental regulations and their impact on clinical research. Our expanded logistical services helps ensure smooth and timely receipt of study materials and can also coordinate the shipment and storage of laboratory and PK samples. As your “In Country Advocate”, GCT will represent your organization with the kind of professionalism and attention to detail you would expect from your own team, except with the regional knowledge and local experience that can only come from years of working within the Region. Please call us and discover the “GCT Experience” for yourself, you won’t be disappointed.

City - Country Population Moscow – Russia 10,000,000 St. Petersburg -

Russia 4,500,000

Kiev - Ukraine 3,000,000 Bucharest, Romania 2,100,000

Sofia - Bulgaria 1,200,000 All City populations have been rounded to the

nearest 100,000

Church on the Blood. St. Petersburg, Russia

St. Petersburg, Russia Moscow, Russia

Sofia, Bulgaria Kiev, Ukraine

Bucharest, Romania Princeton, NJ USA

Phone: 609-731-2225 www.gctrials.com

Experience Across Multiple Therapeutic Areas

CNS Oncology / Blood Disorders Alzheimer’s, Depression, Schizophrenia,

Attention Deficit Disorder, Multiple Sclerosis, Diabetic Neuropathic Pain

Colon, Pancreatic, Prostate, and Breast Cancers, Acute Myeloid Leukemia,

Chemo Induced Nausea and Vomiting,

Cardiovascular Ophthalmology Acute Peripheral Arterial Thrombosis, Hyper-lipidemia, Congestive Heart Failure, Ischemia,

Arteriosclerosis, Coronary Artery Disease

Acute Macular Degeneration (WET and DRY), Subfoveal Choroidal Myopia, Glaucoma, Diabetic Macular Edema

Anti-Infectives Dermatology Community Acquired Pneumonia (CAP), AIDS

HIV Induced Diarrhea, Hepatitis C, Streptococcus pneumonia, Helicobacter pylori

(H. pylori), Urinary Tract Infections

ACNE, Psoriasis, Rosacea, Herpes simplex

Metabolic / Endocrinology Other Studies Type I and Type II Diabetes, Diabetic Foot Ulcer, Rheumatoid Arthritis, Osteoporosis,

Gastroenterology, Diabetic Neuropathy

Surgical Pain, Acute Viral Rhinitis, Stomach Ulcers, Gastric Intestinal

Reflux Testimonials: “Our organization didn’t have experience working in this region of the world so our team was a little anxious. It wasn’t long however before we realized our fears were unfounded. GCT handled everything professionally and completely. They expedited the regulatory process and handled the importation of study drug from beginning to end. GCT made our first experience in Russia a huge success.”

President, US Biotech “This was our second time working with GCT and they impressed us even more the second time around. With the deadline looming for submission prior to summer holiday, GCT worked tirelessly to create the submission package and manage all the translations necessary for us to get approval on time. From that point on we knew we had a team that understood the value of time and could get the job done!”

Director, Clinical Operations, US Pharmaceutical Company “The support GCT provided in helping us get started was incredible. We found the staff to be very customer friendly, and professional. Our project manager, a cardiologist himself, knew every detail about the protocol and the patient population. We found GCT dependable and extremely easy to work with.” V.P. European Operations, Global CRO