Seamless Transition from Clinical Study Sample Collection to Bioanalytical Analysis
We are your single solution for both clinical conduct and bioanalytical analysis. Partner with our scientific experts to seamlessly make your critical go/no-go decisions… and save both time and money.
We make the process smoother by:
- Dedicating a team of scientific experts who are best equipped to walk you through every step of your project’s development
- Using one integrated sample management system, Watson LIMS™, from study sample collection to bioanalytical analysis
- Providing rapid in-house study sample shipping from our clinical site to our bioanalytical labs
- Eliminating time loss for the reconciliation of samples
- Ensuring timely PK analysis of safety data needed for critical, key decision making for later stage studies
Need we say more? Start saving time, contact our experts today.
You may also be interested in the following:
- Fact sheets:
- Webpage: Tell Us Once™
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Altasciences Acquires Calvert Laboratories
Laval, Quebec, May 5, 2021 — Altasciences, a forward-thinking CRO/CDMO supporting all crucial steps in early-stage drug development, from lead candidate selection to clinical proof of concept, announced today that they have completed the acquisition of Calvert Laboratories, a preclinical CRO located on the U.S.A.’s East Coast. This acquisition will complement Altasciences’ current preclinical West Coast operations, located just north of Seattle, WA. For more than 40 years, Calvert Laboratories has been working with clients to help develop the next generation of therapeutics aimed at extending and improving human life; in line with Altasciences’ focus on getting better drugs to the people who need them faster.
“This acquisition will increase small molecule expertise as well as add efficacy pharmacology, ophthalmology, and carcinogenicity study capabilities, to Altasciences’ current preclinical offering. Furthermore, it expands Altasciences’ presence on the East Coast, and the site is conveniently located in close proximity to our CDMO facility,” added Steve Mason, Co-Chief Operating Officer at Altasciences.
Calvert Laboratories has a long track record in the industry as a collaborative development partner bringing extensive experience, an innovative solutions-oriented approach, and unsurpassed performance to preclinical drug development programs. “The entire team at Calvert Laboratories is very excited to join the Altasciences family,” said Michael A. Recny, Ph.D., outgoing Chief Executive Officer of Calvert Laboratories. “The Company can now offer our clients an expanded suite of preclinical and clinical services by leveraging the broad capabilities of a larger and more diversified global CRO.”
“This acquisition is an integral part of Altasciences’ strategic growth plan to provide a comprehensive, fully integrated early phase drug development solution, while addressing the ever-changing outsourcing challenges of biopharmaceutical companies across the globe,” explained Chris Perkin, CEO at Altasciences. “We look forward to working side by side with our new team of preclinical experts on the East Coast, a team that shares our values for excellence, integrity, and customer focus,” concluded Chris Perkin.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
Quantification of Endogenous Biomarkers in Biological Matrices
The quantitation of endogenous compounds in biological methods requires reliable validated assays. Using the required surrogate reference standard (in most cases a recombinant reference standard that allows the relative quantitation of the endogenous analyte) can be challenging. To assess the suitability of the reference standard you need to demonstrate acceptable parallelism between the endogenous analyte and the calibration curve upon multiple dilutions. Our team can help!
Download this insert to find out more about the approaches used by Altasciences to validate and monitor assay performance.
Contact our bioanalytical scientists today for your customized experience.
You may also be interested in the following:
- Webinar: Certificate of Analysis Essentials for Regulated Bioanalysis
- Webinar: Selectivity, Selectivity, Selectivity — a New Dimension by Differential Mobility Spectrometry
- Webpage: Bioanalytical Assay List
- Webpage: Translational Biomarkers
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
Leveraging the Benefits of Microsampling for Safety and Convenience
In a previous blog, we provided an overview of microsampling technology for preclinica
The Lancet: Findings from a Phase I study completed by Altasciences and Novo Nordisk A/S to determine the safety, tolerability, pharmacokinetic, and pharmacodynamics of a drug combination for weight management
25+ Years’ Experience Conducting Early Phase Drug Development
One of the most significant milestones in drug development research is the transition from preclinical to clinical studies. Ensuring risk mitigation at all steps of preclinical and clinical testing, as well as incorporating a thorough safety review plan in the clinical setting, is integral.
Altasciences applies recommendations from world-wide regulatory agencies to ensure that studies are conducted safely, ethically, and in a scientifically robust manner.
We facilitate drug development and save you time by:
- Preparing your preclinical study designs, including species selection and dose level determination.
- Conducting the required safety testing and updating your Investigational Brochure while your IND/CTA-enabling studies are in progress.
- Writing your IND/CTA applications.
- Planning your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human (FIH) trials as soon as you receive regulatory approval.
- Designing your FIH clinical protocol using preclinical study data, including identifying the maximum safe starting doses.
- Timing small-scale drug formulations with clinical conduct to get your trials started sooner.
- Conducting your FIH trials and making quick, informed dosing decisions based on timed bioanalytical data and safety data available within 48 hours.
- Quickly identifying trial findings that may allow you to waive certain studies or provide critical data for safety/dosing considerations in subsequent clinical studies.
Our preclinical, manufacturing, bioanalytical, and clinical teams work closely together to transition drugs through the critical early phases of drug development.
Speak with our experts.
You may also be interested in the following:
- Video: Your Road to Proactive Drug Development with Altasciences
- Webpage: Scientific, Regulatory and Strategic Guidance
- Webpage: Full-Time Equivalent (FTE) Capabilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.