Dear Colleagues and Friends,
The ongoing spread of COVID-19 will continue to have major implications for clinical trial operations as we navigate through unchartered territory, and we’re committed to doing our part to support both the research community and the communities where we live and work. As more and more countries take action to manage and mitigate the impact of coronavirus, we know that we must find our way through this devastating global public health crisis together, by collaborating and supporting each other. Our main objective and social responsibility is to protect our staff, ensure business continuity across our global activities and do all we can to help stop the virus from devastating more families and protect those in society most at risk from COVID-19, especially the elderly.
We are in awe of the physicians, nurses, healthcare professionals and countless other essential workers on the front lines of the crisis around the globe, who risk their lives so others may live. Their efforts to fight this pandemic deserve our gratitude, greatest respect and support.
A historic effort in clinical development is underway, and we’re honored to be part of it. Never before have so many of the world’s researchers focused so urgently on a single topic. Within the next couple of weeks and months, the research community should start getting more evidence from large randomized clinical trials, and hopefully the news will be good.
We wish you a happy holiday with all good health and look forward to better times. Please stay safe and take good care of yourselves and your families.
With warm regards,
Amir Malka, Adv.
President & Co-Founder, Bioforum the Data Masters
Business as usual (virtually)
We at Bioforum are closely monitoring the coronavirus (COVID-19) outbreak to ensure the safety and wellbeing of our employees and partners throughout the world and to enable the continues delivery of our services.
We have implemented a robust continuity plan and arranged for allowing remote support for any ongoing/new projects. We are fully equipped to allow our teams to conduct all activities remotely and hold any meetings via teleconferences.
Bioforum's team staying safe while managing data!
Bioforum is Standing Together With its Partners against COVID-19:
We will grant two Scientific journal articles to be written FREE OF CHARGE
by our highly-experienced medical writers
Do you have results concerning a potential covid-19 treatment or vaccine and need help writing a manuscript to publish them?
Send us a 1 page summary of the study and its results. All summaries submitted by May 15th, will be reviewed by a professional committee, and two projects will be chosen to receive the grant.
Our Partners:
Medidata is monitoring the global impact of COVID-19 on clinical trials, both at a global level but also at the site level as cities, regions, and countries have begun to restrict movement.
Veeva is offering its remote engagement technology for free, in order to help pharma companies and HCPs battle the virus.
Medrio prepared for you a survey to help you understand how your clinical trials are faring in comparison to others.
Mednet is offering a discount program to make it easier for research organizations to conduct urgent and a 50% discount for all new immunology-related research projects
Medidata is monitoring the global impact of COVID-19 on clinical trials, both at a global level but also at the site level as cities, regions, and countries have begun to restrict movement.
Veeva is offering its remote engagement technology for free, in order to help pharma companies and HCPs battle the virus.
Viedoc is offering free licenses to support the global race for a Covid-19 vaccine
Medrio prepared for you a survey to help you understand how your clinical trials are faring in comparison to others.
Mednet is offering a discount program to make it easier for research organizations to conduct urgent and a 50% discount for all new immunology-related research projects
Interim User Guide - COVID-19
CDISC has launched a task force to rapidly develop guidance on standardizing COVID-19 research data with the participation of several member companies. This guidance was released in the form of an Interim User Guide and is freely available on the CDISC website.
Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials
The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19.
European Guidance Released for Sponsors Managing Clinical Trials during Pandemic
The European Commission, the European Medicines Agency, and the Heads of Medicines Agency have published a new guidance for study sponsors on how to manage the conduct of clinical trials during the coronavirus disease (COVID-19) pandemic. It provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations (e.g., if trial participants need to be in self-isolation or quarantine, access to public places is limited due to the risk of spreading infections, and healthcare professionals are being reallocated).
From Our Blog:
No clinical trial sponsor intentionally plans a study migration. Sometimes the decision to migrate data from one database (or data collection platform) to another just can’t be avoided. Once considered a rarity, more and more sponsors are finding the need to switch vendors in the midst of a study. There are a host of reasons for such “rescue” or transition studies, but what’s more critical is developing a strategy and execution plan that ensures the process is as seamless as possible. Study momentum and clinical trial site team motivation must not be compromised. A well-thought data migration plan can help significantly minimize downtime and disruptions to protocol-related activities at investigative sites during the transition.
Alongside data managers, statistical programmers and medical writers, biostatisticians play an integral role in the collaborative effort to develop new drugs and devices. And that’s because biostatisticians are involved in every step of clinical research – from study design to protocol development to data management and monitoring to data analysis and clinical trial reporting to regulatory submission.
But what exactly do biostatisticians do?
