WE SUPPORT
Managing
subcontractors
and partners
The vast majority of entities do not have all the internal resources necessary to perform all stages of development of a product. Thus, they must outsource certain steps to partners or subcontractors with the required expertise.
Based on our experience interacting with stakeholders in the field, we can provide support in the management of external partners and subcontractors:
Define the subcontractor’s scope of work
Ensure the partner complies with the project requirements and produces quality work according to the project schedule
Set up clear channels and means of communication between the two parties
Hold regular meetings to discuss the progress of the project
Manage the partner to ensure that work is performed in accordance with the project’s schedule and requirements
Ensure that the subcontractor maintains the quality, safety and industrial procedures in place that comply with the requirements
Recommend potential changes to the project in a timely manner and then ensure that these changes are taken into account
Communicate relevant information and results from the partner to the appropriate internal project teams.
Analytical
development
and testing
Gene therapy products are complex class of products. It is important that product characterization is carried out all along the development of the product through appropriate quality control testing to ensure product safety, identity, purity and potency.
Before gene therapies can enter clinical trials, their efficacy, safety, tissue distribution and immunogenicity must be assessed in preclinical animal models through specific preclinical studies.
The design of clinical trials of gene therapy products differs from the design of clinical trials for other types of pharmaceutical products. Due to the intrinsic characteristics of these products, specific factors should be evaluated through adapted methods and assays that need to be developed beforehand.
According to the specificities of your program we guide you to determine the analytical development and testing needs required for the product characterization (quality control), the preclinical studies, and at the clinical stages.
National and international grants are essential sources of funding for innovative projects through collaboration.
Collaborative projects
At ZEDGENE we support the project leaders in their effort to initiate and manage collaborative projects. We provide services to unburden both the partner in charge of the coordination of scientific efforts, as well as the partner in charge of administrative activities.
Preliminary services include:
Contribute to partners search
Support in determining tasks of the partners
Support in determining milestones and deliverables
Support in review and aggregation of scientific annexes
During the project:
Communicate with all partners in order to maintain their cooperation and contribution
Monitor progress of the project
Collect and aggregate the documents to facilitate timely reporting
Provide visibility to the project by the creation a project-related website and participation in congresses
Organize effective and efficient project meetings.
