Current Trends in Drug Development
The drug development landscape has been evolving over the years, from an earlier emphasis on blockbuster drugs developed in-house by large pharmaceutical companies, t
A Solution to Drive Your Drug Development Forward
Nonclinical and Clinical Research Services — Phase I to IV
Whether you are looking for a full-service solution or a stand-alone offering, Altasciences will help guide you along the way. We are accustomed to managing complex projects with different partners, and have robust communication and operational processes in place to ensure efficient integration.
We offer a range of services for early phase and late phase studies, including:
- Program Management
- Clinical Monitoring
- Scientific Publication Development and Review
- Protocol Development and Medical Writing
- PK/PD Analysis and Interpretation
- Data Management
- Biostatistics and Statistical Analysis
- Support Services for Non-Clinical Studies
Have 5 minutes? You may be interested in this:
- Clinical Trial Services
- Podcast — Choosing the Right CRO for Your Clinical Trial Monitoring
- Blog — Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
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.
Faster Start to Nonhuman Primate Studies to Meet Planned IND Filing Timelines
Many of you are experiencing significant delays (up to 12 months!) in initiating nonhuman primate (NHP) studies. With Altasciences, the time-to study initiation can be as short as two to three months following contracting, thanks to our steady supply of NHPs.
At Altasciences, we do not rely on a single-source NHP supply chain. We remove the stress of sourcing research animals so that you can start your studies faster, with:
- dedicated and diversified Cynomolgus monkey supply agreements in place to allow for faster start-up timelines
- a continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facility
You can schedule newly contracted NHP studies to start in late Q1 and early Q2 2022 immediately.
Contact us to schedule your NHP studies today.
You may also be interested in the following:
- Podcasts:
- Fact Sheet: Biologics Safety Assessment Capabilities
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.
Manufacturing Solutions for Your Ophthalmic Products
Ophthalmic Drug Delivery
Altasciences’ CDMO experts can support your ophthalmic drug development program for a wide range of ocular diseases. We take you seamlessly from the clinic to market, with high-quality formulation development and manufacturing of various dosage forms, including liquids, gels, and injectables.
Altasciences’ specialties include:
- All small molecule ophthalmic products, including potent compounds and controlled substances
- GMP/GLP-compliant, FDA-registered facility, with DEA License for Schedules I-V
- Class C manufacturing suites for development and clinical/commercial batches
- Flexible filling options, including vials, tubes, multi-dose bottles, cartridges, pre-filled syringes, droppers, and custom containers
- Terminal sterilization of your ophthalmic drug products
- Scale options from small batches up to 400L
- Milling capabilities for micro and nanosuspension products
- Analytical support for method development, validation, and ICH stability testing
- High-performance, mucoadhesive topical excipients
- Bioadhesive, monograph-compliant topical excipients
- Packaging of your ophthalmic therapeutics
- Regulatory, scientific, and operational guidance
Book a consult with one of our experts to learn more about our solutions and how we can support your program.
You may also be interested in the following:
- Fact Sheet: Comprehensive Services for Ophthalmic Drug Development
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Service
Did you miss our webinar titled “The Development of Nanosuspension Formulations for Poorly Soluble Drugs”? View it ON-DEMAND!
NDA-Enabling Study Fact Sheet Available!
NDA-Enabling Studies
The development of an NDA submission plan can sometimes be unclear. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. With over 25 years of experiences, Altasciences' specialists apply their knowledge in designing, conducting, analyzing, and reporting on trials for regulatory submissions, across the spectrum of therapeutic areas.
Our complimentary fact sheet guides you through the different study types and features of NDA-enabling clinical pharmacology studies, and how we can support you.
Want to learn more about some of the requirements for each study? Click on the links below:
- Proof-of-Concept in Special Populations
- Renal and Hepatic Impairment
- Drug-Drug Interaction
- Thorough QT
- Human Abuse Liability or Potential
- Cognitive Assessment Driving Simulation
- Elderly
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.
The Canadian Business Quarterly: Altasciences — Fully Integrated Problem-Solving Solutions
Take a Sneak Peek at Our Kansas City Clinical Facility
Highlights of Our Kansas City Research Campus
Altasciences’ clinical facilities are dedicated to the conduct of early phase and clinical pharmacology trials in a wide range of therapeutic areas. Our Kansas City clinical facility works in unison with our 6 other sites to offer an integrated drug development solution from lead candidate selection to clinical proof of concept and beyond. With over 25 years of experience, conducting 285+ trials annually, our clinics are flexible and adaptable for single or multi-site clinical trials.
Our Kansas City purpose-built clinic features:
- 140 beds
- On-site USP 797 certified pharmacy
- 36-bed specialty clinical unit for sequestering patient populations
- Upscale facility with accommodations that ensures best recruitment and retention
- Dedicated QT unit
- Principal Investigators with psychiatry and epidemiology specializations
- Neuro/CNS specialization — over 40 Human Abuse Potential (HAP) studies conducted
- Full-service capabilities including bio analysis, manufacturing, designing, conducting, and reporting on clinical pharmacology studies required for regulatory submission.
Virtually step inside our KC clinic here.
You may also be interested in the following:
Webpages:
Video: Quick Chat with Dr. Kelsh — Leader in CNS and Human Abuse Liability Studies
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.
Contract Pharma: Altasciences Names Wendell Davis VP, Pathology
Planning a First-In-Human Clinical Trial?
Unique FIH Solutions for Small and Large Molecules
Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. Our FIH solution provides a customized approach that is safe, and delivers quality data with speed and ease.
Access the e-book here to learn more.
This e-book provides an overview of how our unique process can facilitate your early phase clinical program:
- Small molecule manufacturing experts quickly formulating your drug product and delivering it to the clinical site, ready for dosing.
- Coordinated processes running between the clinic and the bioanalytical lab.
- Timed interim sample analysis for proactive dose escalation decisions and rapid turnaround of PK/PD analysis between cohorts.
- Transparent communication between teams and locations, and strict attention to early phase timelines.
- Delivery of high-quality data utilizing our database of over 400,000 normal healthy volunteers and strict safety protocols.
Speak with one of our experts.
You may also be interested in the following:
Webpages:
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.