At Altasciences, our full-time equivalent (FTE) solutions give you access to capabilities and expertise tailored to your requirements. Our experts treat your priorities with the same level of commitment to timelines and deliverables as you do.

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Altasciences’ clinical trial monitoring solutions will help progress your study from initiation to final close-out efficiently, while saving you time and costs. Our team of highly experienced, well-trained CRAs, will work with you throughout the conduct of your clinical trial to ensure strict adherence to protocol and regulations, subject safety, and accurate visit reporting.

Learn more about the benefits of working with Altasciences’ CRAs for your clinical trial monitoring needs.

Robust planning early in drug development can save you both time and money. Altasciences' in-house pharmacokineticists and biostatisticians can work with you to build a robust strategy from the get-go. They are accustomed to managing complex projects with different partners, no matter the therapeutic area — your drug will be in expert hands.

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Sample management at the test facility or clinical site, including sample collection an processing, is a critical aspect of regulated bioanalysis. This is reinforced in the FDA's final industry guidance on Bioanalytical Method Validation (BMV). For meaningful data, every effort should be made to ensure that the analytes' concentration is maintained, from sample collection to completion of bioanalysis.

Are you currently experiencing challenges with SEND, specifically when it comes to timelines? You can rely on Altasciences to ask the right questions from the get-go, to smoothly guide you through the SEND process and help you avoid potential delays in the preparation of reliable SEND datasets for your regulatory submissions.

Contact our SEND team today to experience the difference.

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At Altasciences, we understand your clinical trials are unique and require careful management. As part of our partnership with you, our highly experienced CRAs offer top quality monitoring, through agile and flexible processes and transparent communication. We are up to date with all required trainings, and remain abreast of current legislations, techniques, and technologies.

For more information on Altasciences' monitoring capabilities, contact one of our experienced CRA team members.

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Navigating the SEND requirements can be complicated. By asking the right questions upfront, you'll be able to choose a knowledgeable and experienced partner who can guide you through the process, help you avoid potential delays and prepare reliable SEND datasets for FDA submissions.

Before you choose your SEND partner, read our frequently asked questions and quick pro tips.

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Anatomic and Clinical Pathology datasets are critical when evaluating the safety and efficacy of a drug during the preclinical stage of drug development. Since anatomic and clinical pathology identify and characterize toxicity by different, yet complementary means, integrating both datasets provides a more comprehensive assessment for predicting important toxicities that could occur in humans.

Successful integration requires that anatomic and clinical pathologists collaborate closely. At least one of them must also understand the utility and limitations of both disciplines.

To ensure seamless integration of pathology data into the overall study report, our teams work closely with one another and follows established workflows and communication systems for every project. Additionally, our team can offer guidance on how to best use an integrated assessment for making critical decisions related to your drug candidate.

And, since one of our team members is a dual-certified Anatomic and Clinical Pathologist who brings over 25 years of drug development knowledge to Altasciences, you'll have a trusted partner available to guide you.

To learn more about how we can support you, speak to an expert.

Compliant and reliable datasets for your nonclinical study data are critical for successful FDA submissions. To ensure you are SEND-ready, our SEND team can help guide you through the requirements and the challenges. Altasciences uses submit^TM software to create datasets, and Pinnacle 21 to ensure data integrity.