We are happy to share that Comac Medical has been assigned with conducting Phase 2 randomized, placebo-controlled GULLIVER-2 trial. The results of the study were presented at AASLD The Liver Meeting on 4th-8th November.
Check the results in the following document.
Representatives of our Statistical and Medical Writing Team attended the “Slippery Slopes: Survival Analysis” workshop, which was part of EMWA Professional Development Programme at the 54th European Medical Writers Association (EMWA) Conference.
The workshop gave us an understanding of the analysis of survival in the context of clinical trials. We learned the basics of creating and interpreting Kaplan-Meier graphs and the different elements of reporting Kaplan-Meier analyses. The appropriate graphical and tabular presentation of these analyses was discussed, but the focus was on the interpretation.
This workshop gave us a basic understanding of Kaplan-Meier analyses and helped us to be able to interpret the resulting graphs.
Our Medical Writing Team attended another workshop “The Investigator’s Brochure” as part of EMWA Professional Development Programme at the 54th European Medical Writers Association (EMWA) Conference.
The workshop was focused on learning the ‘theory’ of IB writing, i.e. what the ICH and regulatory guidelines say, as well as tools to be used in successful IB writing. In the second part of the course, participants worked in teams to prepare a mini-IB based on actual data and compare their results to those of the other teams.
With this workshop, we learned useful tools and advice for the actual writing, compiling, and managing of an IB project.
Representatives of our Medical Writing Team participated on Drug Safety For Medical Writers: Part 2 – Laboratory Data workshop, which was part of EMWA Professional Development Programme within 54th EMWA Conference. The role of the medical writer in preparing summaries of safety data are to take a large amount of information and to present the most important points in a useful and understandable format. The challenge for the writer is to identify what is important and to answer the readers’ questions before they have been asked. The aim of the workshop was to improve our approach to writing the laboratory and other safety data sections of documents relating to clinical trials, particularly clinical study reports and to bring the data to life so that the writer can present safety data that are interesting to the reader.
We are pleased to share that Mr. Krassimir Kalinov, Professor in applied statistics at New Bulgarian University and Head of the Biometrics group at Comac Medical, together with colleagues recently published two following articles:
- COVID-19 Infection in Chronic Kidney Disease Patients in Bulgaria: Risk Factors for Death and Acute Kidney Injury;
- Assessment of extrafine beclomethasone/formoterol for the treatment of chronic obstructive pulmonary disease: A non-interventional study in a Bulgarian population
- COVID-19 Infection in Chronic Kidney Disease Patients in Bulgaria: Risk Factors for Death and Acute Kidney Injury
According to the relevant sources, Chronic kidney disease (CKD)-COVID-19 patients are at higher risk of developing acute kidney injury (AKI) and death after hospital admission. This single-center study was performed at Alexandrovka’s Hospital in Sofia, Bulgaria during the period between 1 February 2021 and 31 March 2021 and included 120 in-patient COVID-19 subjects, 70 of whom had CKD and 50 had a normal renal function. The study investigated the risk factors for COVID-19-related mortality in CKD patients, and the secondary endpoint was to assess the risk factors for AKI in patients with COVID-19 infection.
This study was deposited to the MDPI short read archive and is available at the following link: https://www.mdpi.com/2075-4426/12/10/1676
- Assessment of extrafine beclomethasone/formoterol for the treatment of chronic obstructive pulmonary disease: A non-interventional study in a Bulgarian population
Chronic obstructive pulmonary disease is a worldwide major health burden affecting estimated 380 million people and the disease is still rising in its prevalence. The study was a prospective, multicenter, observational non-interventional study investigating about 400 Bulgarian patients fulfilling the protocol criteria. Patients were recruited at 36 sites by 50 investigators specialized in respiratory diseases. The study has been approved by the Ethics Committee for Multicenter Trials of the Bulgarian Ministry of health, Ref No KI-20/ 16.02.2017. The primary objective of this study was the assessment of alterations in lung function parameters FEV1 and FVC over the observation period of 16 weeks. As secondary objectives they defined development of disease symptoms, changes in health impact according to the CAT score test, and the classification of the patients according to the GOLD 2017 categories. As a post-hoc secondary objective they also compared the efficiency of the two devices applied, i.e., of the Foster NEXThaler® and the Foster® pMDI.
This study was deposited to the PubMed.gov short read archive and is available at the following link: https://pubmed.ncbi.nlm.nih.gov/36252915/
Comac Medical’s Head of Scientific Affairs Katerina Markoska took part in two following events:
1. 53rd EMWA (European Medical Writers Association ) conference in Berlin, 3-7 May 2022, where she attended two workshops
-“Medical Writing for Healthy Volunteer Studies”
The unique aspects of clinical trials in healthy volunteers (as opposed to studies in patients) and the consequences of these for writing the key study documents (protocol, informed consent form, clinical study report) were discussed on this workshop.
-“Writing Lay Language Summaries of Study Results according to EU Regulation
This workshop was an introduction to the writing of lay summaries according to the EU Clinical Trial Regulation and similar guidance documents such as the “return of results” initiatives in the US (TransCelerate, MRCT).
and
-“10th EMWA symposium”, which was focused on the rapidly developing field of communicating with the public.
2. 19th Annual Conference of Association Française de Pharmacologie Translationnelle – Le Club Phase 1 – June 16th & 17th 2022 in Paris.
The conference was focused on “Evolution of the approaches and tools in translational and clinical pharmacology”. You can find out more about AFPT through the following link: https://afpt-clubphase1.com/
We are glad to announce that Comac Medical will attend following conferences:
– OCT New England, The Westin Boston Seaport District, 12-13 October
– CPHI, Frankfurt, 1-3 November
– AASLD, The Liver meeting, 4-8 November
– European Site Solutions Summit, 14 – 15 November
– International QA conference, 9 – 11 November
– EBF ICH M10 and OS events, 15 – 18 Nov 2022
Meet with us at the upcoming events to discuss how our expertise, knowledge and broad experience can be fully leveraged to ensure that your projects are managed efficiently.
Comac Medical has the pleasure to inform that we will be participating in this year’s PCMG Annual Outsourcing Assembly in Krakow, Poland from 7-9 September! We are also happy to be one of the sponsors in making this event possible!
The event represents an excellent opportunity for outsourcing and procurement professional working in R&D functions across the pharmaceutical industry to meet and build on partnerships, outsourcing, and operational strategies.
Meet Comac Medical’s expert at the assembly! Vladimir Goranov, Comac Medical CFO, will be there and ready to discuss your upcoming clinical trial needs!
We look forward to meeting you in Krakow and hope to start a dialogue with you or your company.
We have the pleasure to announce that the French Ministry for Higher Education and Research has granted an extension to the approval of Comac Medical’s Clinical Research Unit (CRU) as a research and development service provider. This allows companies, subject to the French General Tax Code, to take advantage of the research and development tax credit (Le Crédit d’Impôt Recherche (CIR) available in France.
French companies which have outsourced research and development to Comac Medical’s CRU will be able to benefit from the research and development tax credit (Le Crédit d’Impôt Recherche (CIR).
The open-data list of approved organizations is available at: https://lnkd.in/dwkdAcU
MEDICAL CENTER COMAC MEDICAL LTD – décision – Agr CIR
For the second consecutive year the owner and CEO of Comac Medical Milen Vrabevski, MD was included in the prestigious medical edition:” The doctors we trust”, issued yearly in Bulgaria thanks to “24 chasa”. The new edition brought together the most authoritative and respected medics in Bulgaria including a total number of 680 Bulgarian doctors, medical centers, managers of medical institutions in Bulgaria and hospitals.
Due to the Covid-19 pandemic, the traditional award ceremony for the medics did not take place. Instead, a discussion was organized between the Bulgarian Minister of Health Stoytcho Katsarov, leading medics and the heads of the largest hospitals in Bulgaria. The topic was “How will Bulgarian healthcare cope with the new waves of the coronavirus pandemic and why the long postcovid is the biggest challenge worldwide?”.
During the discussion, Dr. Vrabevski talked about the need of mobile vaccination centers for the Bulgarian diasporas in Albania, Moldova, Ukraine, Republic of North Macedonia and Serbia.
“As a country, we must pay attention to the Bulgarians living in our historical diasporas. Let’s not forget about these Bulgarians! ”, he commented.
We remind you that in May this year, Dr. Vrabevski initiated and financed the construction of two mobile vaccination centers on the border with the Republic of Northern Macedonia, in which over 5,100 Covid-19 vaccines were delivered in two months.
