Cromos Pharma team publish white papers and articles about clinical trials on regular basis.

2017

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...