By: Irena Lambridis, KCR Director of Quality Assurance & Compliance

For the past 15 months, we have been challenged to find new ways to ensure quality across the organizations and clinical trials we support without the ability to travel to central offices, clinical sites and supplier locations. In many ways, this has been an exciting time that has required us to think creatively and develop more modern approaches.

If we look back at traditional auditing, a single internal audit would involve the following: one day of preparations, half a day of travel, a few days on location to review documentation…

The clinical solution provider is set to offer all eligible employees remote work options

Boston, MA, 29 June, 2021 — KCR, the international clinical development solutions provider, today announced the adoption of a permanent Hybrid Working Model for all office-based employees across all regions of operations.

This flexible, remote working option began as an essential tactic to navigate the COVID-19 pandemic, which involuntarily committed hundreds of employees to shift to work-from-home scenarios.

KCR quickly learned that these circumstances, although a major life shift for many, provided many employees with more time for family, self-care and enhanced work-life balance while maintaining…

KCR recently announced the launch of season two of their in-house podcast on Spotify. The series co-hosts, KCR CEO, Mike Jagielski and CTO, Douglas Bain are back in the studio to cover even more hot topics in the clinical research industry after the success of season one just last year.

The COVID-19 pandemic left us with no doubt that there is a strong and immediate need to digitalize the clinical research industry. In the lastest episode, Bain and Jagielski discuss how KCR’s Digital Solution Framework could help conquer many industry struggles that have been exacerbated by the stress of COVID-19…

By: Dr. Sarah Smith, KCR Senior Consultant Medical Affairs

This year’s PCMG congress was held virtually, with great effort from the organizers to make the event as interactive as possible and to encourage engagement. The program focused on the ever-evolving clinical research landscape, with sessions on the impact of Brexit, wearable technologies, and of course the COVID-19 pandemic on clinical trials.

Focus on the patient experience continues to trend, with excellent presentations from Patient groups on the issues that matter most to them as participants in studies. Strategies to support patients in research (for example adoption of decentralized trials) were…

By: Chief Medical Officer, Anna Baran, MD & Principal Consultant, Dave Li, MD, PhD

The 2021 ASCO annual meeting was held this year from June 4–8, and due to the ongoing COVID Pandemic precautions, all sessions were delivered in a virtual format. ASCO is a conference dedicated to improving equity in cancer research and cancer care, with many of this year’s presentations focused on the racial disparities of cancer care.

Many disease-specific sessions presented the latest results of clinical studies aimed to summarize the data that could impact clinical practice and patient outcomes.

Noteworthy data from the ASCO 2021 Annual…

By: Dr. Karoline Hahn, Senior Consultant for Advanced Therapies

Advancements in the field of advanced therapy redeem the promise of curative treatments for severe and life-threatening diseases. Meanwhile, ten gene and cell therapy products have been launched to the US market1 and more than 1100 advanced therapies are in the pipeline. Moreover, their application is expanding from rare and ultra-rare diseases to more common indications with larger patient population. Consequently, there will be an increasing demand for larger amounts of advanced therapy products.

Manufacturing processes must undergo modernization to be fit for this purpose, overcoming the limitations of current production…

By KCR Senior Consultant for Advanced Therapies, Dr. Karoline Hahn

The Advanced Therapy Congress 2021 again had to be held virtual due to the ongoing pandemic but will be followed-up by an in-person event in London later this year. Nonetheless, it was an exciting event exchanging latest advancements, views, and opinions in the gene and cell therapy space. Hot topics remain manufacturing, immunogenicity and expanding advanced therapies to solid tumors.

The community continues to keep the fast pace and shoves into more common diseases like diabetes I or even Parkinson. Solid tumors are coming into the focus, too. However, some…

Iwona Kiezun, Head of HR, KCR

In recent years, careers in the clinical research industry have become much more desirable. Many recent graduates recognize the possibility of developing life-changing therapies and seek to join a clinical research or life science organization right after graduation.

As a result, the life science industry now has a highly selective talent pool with the proper education, skills and experiences for key roles. Due to the complex nature of the work, research professionals are quite multidimensional, and candidates need to be technically skilled with regulatory knowledge, medical expertise and data science proficiency while maintaining a…