A statement from the Bionical Emas Group on guidance & measures regarding COVID-19 - read here

In relation to staff and visitor safety, we have full risk assessments in place for all of our workplaces. These risk assessments are revisited and updated regularly, to reflect changing risks, knowledge and circumstances, and to reflect evolving Government guidance. We have not placed the risk assessments here on the website as they would become out of date too quickly. However, you are welcome to email info@bionical-emas.com to request access to our most up to date risk assessments applicable to your needs. Please note that all our staff are notified of all applicable risk assessments and updates, along with ‘quick guides’ automatically via our e-learning system.

HomeResource LibraryOperational Flexibility and Adaptability

The flexibility and adaptability required to successfully manage an operationally complex adaptive clinical trial.

Outline.

Bionical Emas are providing full-service CRO support for a modular, multipart, multi-arm, early phase study to evaluate the safety and tolerability of a novel IMP alone and in combination with standard of care therapy in patients with advanced malignancies.

Challenges.

Flexibility and adaptability required to move quickly and keep things on track with ever-changing study requirements. Conducting multiple parts of a complex modular study at the same sites and keeping the site teams well trained, motivated and adequately resourced.

Tactics.

  • Expertise in this area: Crucial factors for success include our expert operational knowledge in running complex and early stage oncology studies; an in-depth understanding of the unique and patient specific approach to treatment management; and our ability to provide a specialised clinical team.

  • Transparent Governance Structure: We have transparent and open relationships between senior management, providing a clear pathway between executive teams to discuss the progress of the study and future plans to ensure that the project continually drives forward.

  • Program approach to Project Management: It is imperative to ensure that modular studies are adequately resourced, and treating each module as a standalone project within a program allowed us to assign a Project Manager to each module and a Program Manager as a key client contact point. We have separate key deliverables and processes for each module, whilst taking advantage of interdependencies between modules to add efficiencies and reduce costs across the program.

  • Highly flexible SOPs: Allow us to adapt and develop processes quickly to meet specific needs, without compromising patient safety or data integrity. Most recently, we implemented a COVID19 risk management plan to adapt our central data review procedures and prevent a lull in data cleaning.

  • Site Management: Even the most experienced sites can struggle with complex protocols. Our mitigation strategies have included having separate core and module specific Investigator Site Files for easy identification of documents, preparing site-specific R&D review packages, and having one CRA for each site to ensure continuity across modules and develop stronger relationships with site staff.

  • Modular eDC: As certified IBM Clinical Development builders, new modules can be built quickly in as early as two weeks if required. With this cost-effective measure, each modular database is open for a shorter time, Investigators have one login with all modules listed, helping them to enter data correctly, and it prevents having a half-locked database.

  • Medical Monitor Led: Our Lead Medical Monitor regularly discusses anticipated protocol changes with the client’s Senior Medical Director, and disseminates information to the project team early, which is important for clarity with a constantly evolving study. Medical monitors also attend all project calls where they identify and address training needs for the project team and site staff.

  • Visual Medical Monitoring: For medical review of safety data, eDC datasets are combined across modules into graphical visualisations, allowing a more comprehensive review of data. For example, the start and end dates of all Adverse Event types can be visualised against dosing days.

Successful Outcome..

To date, Bionical Emas have screened 162 patients, and enrolled and dosed 115 patients with multiple types of solid tumours, across 9 protocol parts over 3 years, and have met evolving deliverables on time.

Our expertise in this area have enabled our client to save at least 6 months in time and cost, compared to running the clinical trials with multiple traditional protocols.

  • 162 Patients screened

  • 115 Patients enrolled and dosed

We welcome future opportunities to offer our expertise in the delivery of complex and challenging adaptive design studies.

We can support you with…

Clinical Development

At Bionical Emas we understand that individual biotech and pharma companies have very different needs. All our clinical development services can be tailored to meet those individual requirements. From a standalone service, to a fully integrated large global clinical trial, the Bionical Emas team, has the expertise and experience to support and deliver our clients clinical development plans.

Explore

How can we support you?

Our dedicated teams of experts are on hand to help should you require any additional resource or further information about our services.