Our team of experts regularly publishes insights and analysis on some of the most topical subjects relating to clinical trials. In addition our team contributes country profiles that are designed to familiarize potential sponsors with the advantages of some of the venues Cromos Pharma has extensive expertise in. Other papers cover regulatory subjects including updates from the FDA and EMA. In 2020, we launched a new Insights@CromosPharma series featuring some of the latest trends in the clinical trials space as well as exploring some pioneering clinical technologies and techniques relevant to the industry. If you have any questions or comments please contact our team at inquiry@cromospharma.com.




 
Country Profile: Clinical Trials in the Republic of Georgia

September 2020

With its rapid regulatory approval process, significant naïve populations in a range of therapeutic areas, skilled medical personnel and a conducive economic environment for doing business Georgia is regarded as a hidden gem for those interested in initiating novel studies and rescue trials. 
Read our Clinical Trials in Georgia profile here

Watch our video here:

Reasons to conduct your next clinical trial in Georgia

Country Profile: Clinical Trials in Hungary

August 2020

Hungary boasts several advantages for international sponsors conducting clinical trials: rapid recruitment potential, EU        membership,  skilled and motivated clinical professionals and a strong record of producing high quality data. Hungary is placed 10th worldwide in terms of the number of trials conducted in the country and 4th in Europe (based on population-proportional patient numbers). Each year approximately 20,000 patients participate in clinical trials in the country.

Read our Clinical Trials In Hungary profile here 

Watch the video:

Hungary_video_.jpg

Case Study: Rapid recruitment for psoriasis studies
September 2020
Cromos Pharma prides itself on its proven track record in achieving recruitment targets for our clients’ studies. Our expert team consistently meets and exceeds recruitment goals for difficult to enrol trials. This case study describes the successful and rapid recruitment of two psoriasis clinical trials by our teams in Ukraine and Georgia. 
Read our case study here
Watch our video here

Clinical characteristics of dermatologic manifestations of COVID‐19 infection
July 2020
International Journal of Dermatology
Nikolai N. Potekaev MD, PhD Olga V. Zhukova MD, PhD Denis N. Protsenko MD, PhD Olga M. Demina MD, PhD Elena A. Khlystova MD, PhD Vlad Bogin MD
This article co-authored by Cromos Pharma CEO Dr Vlad Bogin and published in the International Journal of Dermatology (3 July 2020) examines the dermatologic manifestations of COVID-19. It includes a case series of 15 patients, review of literature, and proposed etiological classification.
Read the full article here


Insights@CromosPharma: Risk Based Monitoring
A data centric approach to managing CTs
June 2020
In this Insights@CromosPharma article our Chief Operating Officer Stephanie Finnegan explores the role of Risk Based Monitoring (RBM) in clinical trials, how it has been utilized in response to the current coronavirus pandemic, and how the experience may shape the industry's approach to RBM in the future. 
 Read the full article here

Master protocols: New directions in drug discovery: Contemporary Clinical Trials Communications
April 2020
This article written by Cromos Pharma CEO Dr Vlad Bogin and published in the Contemporary Clinical Trials Communications Journal (published online 25 April 2020) outlines the reasons why clinical trial professionals need to understand both the basic principles of master protocol trials and the way innovative trial designs are starting to change the landscape of clinical research.
Read the full article here

Insights@CromosPharma: Master Protocols
March 2020
The recent uptake in the use of master protocol trials is a direct result of increasing focus on targeted therapies for difficult to treat diseases, biomarker-driven research and personalized healthcare. As part of Cromos Pharma’s new Insights series, Dr. Vlad Bogin, CEO, has produced a presentation “Master Protocols: New Directions in Drug Discovery”. The 12-minute talk provides an overview of the guiding principles of master protocols, discusses its three most widely used study designs - Basket, Umbrella and Platform - and explores some of the successful case studies associated with this new direction in drug discovery.




Clinical Trials in Poland
April 2020
With almost 40 million people Poland is one of the largest clinical trials markets in Eastern Europe that has a strong track record of over 20 years in delivering high-quality research. Cromos Pharma presents this Country Profile "Clinical Trials in Poland" as one of our forthcoming series of reports about clinical trials in Cromos Pharma's geographic regions and topical issues in clinical research. 
Read the full paper here


 2019

Our medical writing team is focused on delivering the results you need.

High quality medical and regulatory documentation play a central role in the success of any clinical study. Cromos Pharma’s medical writers combine medical, science and technical writing to produce high quality documentation to support all aspects of your clinical research. Our experts have vast experience in delivering accurate and concise documentation in a wide range of therapeutic areas. Read more...

2018

Clinical Trials in Poland: review of the first half of 2018 based on data from ClinicalTrials.gov

Emerging markets (CIS/CEE/Asia-Pac) continue to attract the increasing number of clinical trials and Poland remains the largest clinical trials market in the region. Read more...


Clinical Trials in Georgia: review of 2017 based on data from ClinicalTrials.gov

The Cromos Pharma team is pleased to share with you, information on the clinical trials market in Georgia for 2017. All data for analysis has been taken from the website https://clinicaltrials.gov. Read more...


2017

Clinical Trials in Kazakhstan: Open For Business

Cromos™ Pharma shares its experience with clinical trials in Kazakhstan in Applied Clinical Trials journal. Read more...


The New EU Clinical Trial Regulation (No. 536/2014) and Investigator-Led Studies

The new EU Clinical Trial Regulation (No. 536/2014) will need to address current shortcomings if important investigator-led studies are to continue. Read more...


2016

Georgia - Hidden Gem for Clinical Trials

This white paper gives a comprehensive overview of clinical trial landscape in the Republic of Georgia, which is becoming a very attractive location for clinical trials. Read more...

2015

Update on Regulatory Approval Timelines and Local Requirements in Selected Countries of the Former “Eastern Block”

The complexity of regulatory approval pathways and time to "first site initiation" play a significant role in the decision as to which countries to include in an international clinical trial. As these parameters periodically change, this white paper is intended to give an update on both the timelines and the existing or emerging requirements that Cromos Pharma faces in its countries of operation. Read more...

2014

Russia Scales Its Efforts To Reduce Dependence On Foreign Drugs

The “Working Group on Preferences for Domestic Producers”, chaired by Vice-Premier Olga Golodets, will soon approve the official position of the Russian government on the admission of foreign manufacturers and their preferences for domestic companies in government procurement programs. The working group is proposing several standardized plans designed to assist and bolster Russian pharmaceutical companies. Read more...

Strategic vs. Transactional Partnerships Between Pharma and CROs: One Size Doesn’t Fit All

Despite some recent encouraging momentum, investments into Pharma R&D have been on the decline. The Pharmaceutical Research and Manufacturers of America (PhRMA) noted a drop of 0.3% in its members’ spending on R&D, to just under $49 billion, in 2012. 2013 didn't look much different either. It is unclear how 2014 will shape up, but 10-15% spending surges that were not too uncommon in the 1990s are clearly the things of the past. Read more...

Clinical Trials in Ukraine: Current Status and Short Term Outlook

For almost two decades Ukraine has been an attractive locale for clinical research, in large part due to its rapid patient recruitment and sound investigator expertise. In the last several months the political situation in Ukraine has become rather volatile and remains the epicenter of international contention. Albeit, in this brief report we will forego both political and economic analyses, leaving it to the experts. The goal is to provide a brief status update on the ongoing clinical trials and give recommendations on how to mitigate both present and future risks. Read more...

2013

All Global Clinical Studies Are Local

Global clinical studies are very complex. Even minor oversights during the planning stage can result in significant problems. The following issues often do not receive the attention they deserve. Read more...

Clinical Trials in Belarus – Deserving of a Second Look

Until very recently Belarus has been considered a country where clinical research was a difficult undertaking. Unlike Russia and Ukraine, where the number of clinical trials has grown over the years, Belarus has remained relatively uninvolved in clinical research. For a country with well developed medical infrastructure and a high quality of patient care this paradox stemmed from unfavorable regulatory environment. Flawed with bureaucratic roadblocks and lack of incentives for participating investigators, Belarus remained behind on the international research front. However, with the latest legislative concessions, the situation has changed dramatically, prompting us to share these new and promising updates along with a brief overview of Belarussian healthcare system and its improved potential for clinical research. Read more...

Clinical Study Rescue: Where to Find Peace of Mind

Conducting an effective and high quality clinical trial as part of a drug development process is a monumental undertaking. The complexity of this task easily surpasses the development of almost any new product in any field. Each study starts with a meticulous design, very thorough analysis of inclusion and exclusion criteria, and selection of the best suited vendors, investigators and sites. Diligent and extensive preparation for study launch is a must and every possible scenario should be dissected. However, even the most painstaking prelaunch readiness activity does not always translate into smooth study conduct and on-time delivery. Recent analysis of all pivotal clinical programs revealed that close to one-half ended up missing the anticipated timelines. These delays translate into late submissions to the FDA, late approvals of the NDAs and late market entry. Not only does this cause loss of profitability due to shortened patent life, but also loss of market share in the event that such delays translate into a competitor’s product being first to market. For Pharma and biotech companies of any size, these issues have serious consequences with a price tag of up to $1 million in lost revenue for every day of delay. Read more...

Cromos Pharma’s Update on Registration of Medical Devices in Russia

The purpose of this white paper is to discuss the new regulatory requirements for registration of medical devices that were put forth by the Russian government on December 27, 2012. January 1st, 2013 has supposedly marked the end of the era of vagueness in the field of medical device registration in Russia. Prior to this date, device manufacturers had no clear understanding of what processes to follow when it came to submission; what questions, quarries and deadlines to anticipate. The guidelines as to which governmental agency was responsible for which step of registration process were unclear. All these uncertainties are now in the past, or are they not? Read more...

2012

Cromos Pharma’s Update on Drug Registration in Russia

The number of active clinical trials in Russia has increased significantly during 2012. Much of this increase can be attributed to new regulatory requirements put forth by the Russian Ministry of Health (MoH) which went into effect in September 2010. This “Circulation of Medicines” law affects both domestic and international pharmaceutical manufacturers in very significant ways. For international firms intending to market its products within the Russian Federation, undoubtedly the most important provision is a new requirement wherein Russian patients must be included in the company’s pivotal phase III clinical trials. Assuming that the aforementioned Phase III trials have not already been completed, this requirement can be met by one of two mechanisms: (1) enrollment of Russian patients in trials that are yet to be undertaken; or (2) under circumstances wherein an international treaty(s) exists between Russia and another country (or jurisdictional authority) that provides for mutual exchange of clinical study data, there may not be a statutory need to conduct one or more domestic registration studies in-country. In the absence of the two qualifying conditions as stated above, the most direct and expeditious route leading to the right to market and sell Pharma products within the Russian Federation is to repeat a properly designed and powered registration trial using Russian subjects. Read more...

New President Steps In With a New Decree

On the day of his inauguration, newly re-elected President Putin had issued 11 new Decrees. The one that we share with you is the Decree "On Improvement of Public Health Policy". While some parts of it are nonessential, the document is quite entertaining and thus we present it to you in its entirety. Please see our analysis below. Read more...

2011

Russian Clinical Trial Market: 2011 in Review

2011 has been a turbid year for the Russian clinical trial market. The Russian Federal Law on Circulation of Medicines which came into force on September 1st 2010 introduced special requirements to registration of new drugs on the Russian market, with the most relevant part being a requirement for a local registration study of the drug being registered. Read more...

2010

Russian Clinical Trials Market: January – June, 2010 Comparative Analysis

For over fifteen years, Russia has conducted pivotal international clinical trials. In addition to the immediate benefit of a more expedient introduction of new pharmaceuticals to the market, such trials add a significant component of investment to the Russian economy. Furthermore, participation in clinical trials has a high social value for the Russian medical community – specifically, the ability to adapt the most progressive medical standards for pharmacology as well as establish direct contact with key opinion leaders of the international medical community. Clinical trials stimulate local pharmaceutical research and development, and Russian patients gain access to groundbreaking medical treatments and technologies. Free medical care utilizing high caliber technology is often the only way for many Russian patients to be included in state-of-the-art treatment programs. Those in this field understand that the participation level in international clinical trials reflects on the status of a country’s medical care. Despite recent advancements, it is clear that Russia still lags behind other premier medical communities in terms of the quantity of clinical trials. Read more...

FDA in Russia: Current and Future Trends

A pivotal meeting between FDA and Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (RosZdravNadzor) took place on May 27, 2010 in Moscow. The head of FDA, Dr. Margaret Hamburg and the head of RosZdravNadzor, Dr. Elena Telnova have signed a letter of collaboration. This letter describes future steps in cooperation between the two agencies. During press conference Dr. Hamburg noted that FDA is very interested in building a strong relationship with Russia that will help advancing information exchange, harmonization, and joint efforts in curtailing diseases. There is a desire on both sides to press forward with the effort of global reinforcement of good clinical practices in the field of clinical trials. Read more...

Current and Future Trends in Russia’s Pharmaceutical Market

Despite global economic downturn Russian pharmaceutical market remains strong and continues to attract foreign companies. With sales of medicinal products exponentially rising over the last 10 years and remaining grossly unaffected over the last 24 months, both large and midsize Pharma are actively expanding its presence in this market. The forecast for the next 10 years suggests a robust growth of pharmaceutical sales. Read more...