Regulatory Affairs
Regulatory Comparisons for Starting First-In-Human Clinical Trials
Exploring the Advantages of Canada for Early-Phase Clinical Trials
Where you decide to conduct your early-phase clinical trials could have a significant impact on your costs and timelines. There are lots of factors to consider when making that decision—in some cases, performing clinical trials in Canada and the U.S. simultaneously can be the right step towards optimizing your program. But as sure as maple syrup is great on pancakes, and mustard is better on hot dogs, some things are simply just a better fit.
Top 10 Life Science Resources - October 2023
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!
You have questions; we have answers.
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Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines
Drug Development Timelines: How Health Canada’s 30-Day Regulatory Review Process Could Provide an Advantage
We want novel therapies to be approved fast, while being safe for us. Regulatory agencies around the world strive to balance the critical elements of speed and safety; at the same time, a rigorous review process is a must.
Five Reasons to Choose Canada for Your Clinical Trials—From the Webinar Demystifying the Conduct of Clinical Trials in Canada
Canadian research facilities are becoming a popular choice for American and European sponsors, carrying out hundreds of clinical trials each year.
Best Practices for a Successful, Multi-Step Data Journey
In this latest issue of The Altascientist, we guide you through the complex, multi-step data journey for Phase I clinical trials, from study conceptualization and protocol development, to data collection and analysis, through to final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.
Speak with an expert to learn more about our service offering.
Have a few more minutes? Check out these insightful resources:
- The Altascientist—CDISC Data Standards
- Fact Sheet—Comprehensive Research Support
- Blog—Data Management Excellence
Quality is OUR Priority
Our Laboratory Sciences Compliance Group is focused on quality, as well as on delivering critical drug biomarker quantitation data throughout each drug development phase.
We provide you with:
- Regulated bioanalysis across a wide range of analytes, including small molecules, biologics, bioequivalence, bioavailability, drug to drug interaction studies, and oligonucleotides
- Process audits and facility inspections
- Quality management systems
- RQAP-GLP Registered Auditors actively involved in the U.S. and Canadian regulatory communities (SQA, PRCSQA, CCSQA)
- Risk assessment quality audit plans
- On-site inspections and study-specific audits
- In-house Regulatory Team to ensure trials are conducted per protocol and within ICH/GCP/CFR guidelines
- Vendor qualifications
- SOP management
- GLP recognition-compliant archiving
You may also be interested in the following:
Join Dr. Kaylyn Koenig, on November 30th, for a conversation about digital droplet PCR (ddPCR) in preclinical research, including how it compares to qPCR.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Medical Writing Expertise Is at the Heart of Your Submission
Collaboration and communication means quality documentation for your drug development program. Our Medical Writing teams collaborate constantly with our experts and yours, ensuring that very scientific document required for your study is accurate, complete, and-compliant with regulatory guidance. From initial protocol to the final clinical study report, we deliver rapidly, without compromise.
As a stand-alone solution, or part of an Altasciences study program, our Medical Writing team is ready to support you. You can work in unison with us on a Full-time equivalent (FTE)basis, or project by project, the choice is yours.
