HOW WE HELP BIOTECH COMPANIES TO DE-RISK THEIR DEVELOPMENT PROGRAMS?
Strategise for success and engage early
Aim for excellence in clinical trial management
Gather high quality evidence
We validate your ideas with Regulatory Authorities, Key Opinion Leaders and service providers early in the development process.
Their insights can:
shape the direction for your product development program
define its relevance to patients
inform about commercial considerations
map the complete development pathway
provide guidance on clinical trial endpoint selection.
Those interactions can help identify the key opportunities, navigate the potential risks and learn about the expectations directly from the regulators.
It is critical to set the trial on the right path from the start, so we meticulously map the necessary steps and plan for success.
We carefully plan the study design and ensure the appropriate endpoints are selected to achieve meaningful clinical trial results.
We assist in choosing the best fit clinical vendors.
We have hands-on experience in selecting, qualifying and overseeing clinical partners such as CROs, laboratories or CMC providers. While trust and a collaborative approach are key, we ensure the expected quality by open communication, tracking performance metrics and promoting a quality mindset among project collaborators.
Risks in each trial must be assessed - reach out to us for complementary tools for risk management.
We focus on milestones and spell out the necessary steps to progress as per anticipated timelines.
We take responsibility for the budget oversight, smooth project progress and we evaluate risks on an ongoing basis.
We are driven by results and aim for excellence which makes AnRes Clinical an excellent partner supporting you in reaching your ambitious goals.
Clinical monitoring is a regulatory mandated sponsor's responsibility of ensuring patient safety and clinical data integrity. Since our CRAs understand the study endpoints, they focus on the data that really matters for safety, efficacy and performance evaluations.
We ensure that CRAs channel all effort towards excellence, understanding the intricate issues of the protocol and the indication, and towards building strong relationships with site staff.
We believe focusing on those aspects is the basis for outstanding clinical monitoring service.
CONTACT US NOW TO SEE HOW WE CAN SUPPORT YOUR PROJECT