Clinical development strategy
100% of our projects have started with clinical development strategy
Understanding the corporate strategy and key performance indicators of our clients allows us to build a tailored clinical development strategy to create and add value and allocate capital for best return on investment, meeting our client’s objectives and milestones.
Be it to design a basket trial to generate actionable data, to identify experts or vendors to best support you trial, to assist you with submissions, to perform risk analyses, or to assist you in any other way, contact us.
We can also help with:
Devising and prioritising clinical development plan
Optimising clinical operations by advising on protocol design and trial execution
ILife Consulting clinical development strategy from a client perspective
Clinical gap analysis
Is your clinical operations’ organization working optimally?
To avoid the negative impacts of any delays, you may decide to proactively have your clinical study processes and procedures reviewed to identify any potential source of dysfunction, to evaluate individual or team performances, or get reassurance that the conduct of the clinical study and the interactions between your clinical team and different parties are optimal.
Safeguarding your clinical studies
To address resources limitation, ILife Consulting appoints a seasoned clinical project manager to assist with the CRO selection process, coordinate and supervise your clinical trial and provide strategic clinical input on a short, medium or long-term basis. We provide clinical advice and clinical oversight to de-risk the clinical trial execution performed by the selected CRO
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Recruitment and training
Do you want your collaborators to master the clinical oversight?
At ILife Consulting, our seasoned Clinical Project Managers master the clinical trial tools, systems and procedures and have a handson approach. Their experience provide them with valuable input to support the recruitment and training of your Clinical Operations collaborators.
Our Clinical Project Managers are able to step in and out to train and upskill to regulatory and GCP standards members of your team.
Clinical study conduct
A well-planned clinical trial requires the identification and objective assessment of all potentially study-impacting factors.
At ILife consulting, we rely on the experience, accountability, integrity and project-ownership of our clinical operation team.
Study start up
Setting-up your clinical trial for success
Some of the most impactful drivers to the study timeline are the time to obtain regulatory approval, the time to obtain a site’s “green light” to start patient screening and recruitment. Regulatory approval timelines in Europe can be kept in check by providing clear, complete and concise documentation at the time of submission. ILife consulting can mitigate the risk of prolonged approval timelines by ensuring the quality of your submission package.
Clinical regulatory submissions
The key trigger for the initiation of submission activities is the availability of final core documentation, such as the protocol and Investigators’ Brochure (IB) in Europe, approximately three to four weeks before the initial submissions to the Competent Agencies (CA) and Ethics Committee (EC) or the approval of the Investigational New Drug (IND) application in the USA. ILife Consulting will prepare a customized submission plan including a list of required documentation as well as define responsibilities and detailed timelines.
In Europe, ILife Consulting Clinical Project Manager will perform the CA and EC submissions until approval is granted. Our Clinical Project Manager will:
Be the primary regulatory point of contact
Develop and manage the submission plan
Compile the core submission package
Track the submission status and follow-up until approval
Coordinate the compilation of query reply documents
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Owning your project for your peace of mind
Clinical project management is a central activity for us. Our project managers master the entire process from study initiation to study close out and oversee all activities, having regular contacts not only with our clients, the investigator sites study teams but also with all the vendors and preferred partners ILife Consulting is given the responsibility to manage.
Our clinical project management activities include but are not limited to:
Centralized project management for optimal communication
Dedicated project management team
Coordination of the development and approval of the clinical trial documents: Monitoring Guidelines, Statistical Analysis Plan, Data Management Plan, Safety Management Plan, ICF, CRF…
Clinical trial documentation management
Comprehensive time and budget management
Site contract negotiation
In-house CTMS for continuous process optimization and transparency
Initial Clinical Trial Application (CTA) submissions & amendments to Ethics Committees and Competent Authorities through the CTIS systems
Support to address regulatory authorities’ comments
Risk management assessment
De-risking your trial to save time and generate clinical data of value
Risk-adapted quality management assessment is a continuous process which spans throughout the entire clinical study. As part of our project management and through an agreed Communication Plan, ILife Consulting’s project team will perform an initial risk assessment to identify potential risks based on the protocol, project scope, and study-specific details. In addition, a Mitigation Plan is put in place for each identified risk. Risks and issues are proactively anticipated and reviewed as part of the regular external and internal team meetings.
Power in like-minded partners
As part of a continuous improvement process, ILife Consulting is always keen on establishing new partnerships with like-minded service providers that will offer similar benefits to our clients and agility through size. ILife Consulting has established partnerships with data management, statistics, vigilance service providers, niche CROs in selected countries and a global, exemplary, Oncology clinical trial sites network.
We manage, but usually do not contract third-party providers for eSolutions (eCRF, eDiary / eCOA, IRT and eTMF), clinical trial supplies and operational supplies to de-risk your outsourcing strategy. Every vendor is carefully evaluated before selection and regularly assessed.
Clinical monitoring & site management
Safeguarding the quality & integrity of your clinical data
Site training, motivation, and meticulous clinical monitoring in accordance with ICH-GCP standards are crucial to obtaining quality study data. ILife Consulting conducts clinical trials throughout Europe with the help of office-based CRA employees and long-term freelance CRA collaborators who closely manage site performance to avoid protocol violations, maintain low query rates, and ensure study enrolment as well as on-site logistics throughout Europe and provide remote monitoring in North America.
Consistent, high-quality clinical monitoring is ensured through periodic co-monitoring of all trials, coupled with project-specific monitoring plans, periodic CRA training and mentorship.
In addition, ILife Consulting Clinical Trial Management System (CTMS) is particularly user-friendly and accessible to all.
Local experienced CRA (permanent office-based employees and network of dedicated freelancers)
All monitoring activities in accordance with ICH-GCP standards
Co-monitoring and training programs to ensure quality across all sites and countries
On-site and remote monitoring
Site overview and proactive site management
Site training and support with the study documentation
Patient recruitment strategies
Scientific and medical writing
Understanding your innovation to successfully move it forward
With a wealth of expertise drawn from the industry and academia, ILife Consulting team can develop your clinical documentation to deadline, saving you time and money in the process.
Our knowledge spans across multiple therapeutic areas and product types including small molecules, recombinant proteins, gene therapies, cell therapy, combination products plus others.
We can elaborate documentation required during the clinical development including but not limited to :
• Synopsis and protocol
• Monitoring plan
• Informed Consent Form
• Pharmacy Manual
• Standard Operating Procedures (SOPs)
• Case Report Form (CRF)
Likewise, existing documentation can be assessed and completed by our team.