CRO SERVICES FOR CLINICAL RESEARCH

As part of our preclinical offering, we perform comprehensive formulation and analytical services, and have the expertise to ensure your method development is compliant and reproducible. We provide a full range of analytical support ranging from characterized assays to meet pre-GLP lead optimization needs, to feasibility, method development, method transfer, method validation, and sample analysis for both preclinical and clinical phases of development. We understand the importance of properly evaluating your test article and are here to provide you with key analytical support to drive your small or large molecule forward.

Our range of services includes histology, histopathology, light and electron microscopy, immunohistochemistry, immunofluorescent staining, and cell morphometry. Our professional teams include histologists, who perform comprehensive histology services compliant with good laboratory practice (GLP) regulations, and highly experienced board-certified pathologists to provide expert histopathologic tissue analyses, scientific reporting, and study consultation.

We offer state-of-the-art, GLP-compliant archiving solutions in a purpose-built, stand-alone facility that can archive both dry and wet tissue samples, including:

• Experienced and dedicated staff, including a Lead Archivist
• Archive Management Database
• Secure transfer services for paperwork, specimen and cold storage samples
• Secure destruction for all materials onsite
• Duplicate CDs to maintain integrity of electronic data
• Annual verification of materials through a facility audit

We offer the following GLP-compliant archiving solutions within an HVAC-controlled environment:

MATERIAL STORAGE CAPABILITIES

• Wet tissue
• Blocks
• Slides
• Paper data
• Frozen samples

SECURITY SPECIFICATIONS

• Secure netting to ensure protection of data
• 24-hour security and monitoring system
• Secure, limited access

FACILITY ASSETS

• Ultra Low Storage Freezers
• Archive Management Database
• Advanced FE25 Gaseous Fire Suppression system

Our biostatisticians and statistical programmers work in synergy with internal colleagues and departments to provide you with timely, high quality statistical services, in accordance with regulatory requirements. Consult our Biostatistics Services Fact Sheet.

Fully aligned with current data standards, the CDISC experts that are part of our CRO services team can help you with the seamless implementation and migration of data standards in support of our clinical pharmacology services.

Altasciences’ CRO services includes a team of highly experienced, well-trained CRAs to expertly oversee all the relevant aspects related to conduct of your clinical research. Their individualized attention ensures compliance with your protocol and GCP as well as securing patient safety and data integrity.  Our CRAs are dedicated to monitoring all the details of your study, from initiation to final close-out, including the following:

• Site selection and qualification according to established criteria and subject population
• Initiation of study centers to the study protocol and plan
• Performance of source document verification to ensure GCP, patient safety and data integrity
• Review of on-site regulatory documents to ensure compliance
• Review of the eCRF between visits 
• Preparing timely, comprehensive correspondence and site visit reports
• Effectively working with sites to close-out the study, resolve outstanding queries, and return IP

We work with the study site to foster excellent performance through training, mentoring, and managing study personnel. Our clinical monitors oversee the progress of your study, ensuring strict adherence to protocol and regulations, safety of subjects and accuracy of visit reporting. Our monitoring plans can include standard on-site monitoring, central monitoring, risk-based monitoring, or a combination of approaches to meet your needs.

Our clinical pathology laboratory staff has extensive knowledge of animal hematology (protocol-driven, ~17 parameters available), coagulation, clinical chemistry (~40 parameters), and urinalysis (dozens of parameters available, depending on study protocol). Specialized pathology laboratory services, such as thromboelastography (TEG) are available to meet your program assay or biomarker development needs. We design the clinical pathology component of protocols to optimize the opportunity to achieve study objectives so that all data generated can be interpreted with confidence in the relevant species.

We work with you to translate your clinical study design into the protocols and technical execution that drive effective study conduct for small and large molecules. Our CRO services team includes knowledgeable scientific minds, always attuned to your program needs.

We have developed a strong reputation for delivering high quality, reliable, and responsive medical writing to sponsors around the globe, as part of our CRO services offering.

Our sample management kits provide all the materials necessary for accurate, efficient and safe preparation, collection, and shipment of clinical samples from trial sites to bioanalytical laboratories. Our kits are adapted to your specific study needs, with color-coded, pre-labelled tubes, personalized laboratory manuals, pipettes, needles, cotton balls, etc., for use with many different matrices such as plasma, urine, serum and whole blood.

Leveraging extensive data, our global network of 100+ clinical sites and unrivalled industry knowledge, we are uniquely positioned to support enrollment in healthy normal volunteer and specialty population trials.

We deliver comprehensive data management services using efficient and meticulous processes, coupled with state-of-the-art technologies to ensure your clinical trial data is managed with precision and accuracy. Consult our Data Management Services Fact Sheet.

We facilitate and expedite delivery of our comprehensive suite of Research Support Services through a Full-Time Equivalent agreement (FTE) option that offers maximum flexibility, and ensures you have consistent access to our experts through the different phases of your drug development program.

Our team provides extensive PK/PD support in preclinical and clinical studies in accordance with FDA, Health Canada, EMA, and ICH guidelines.

High quality project management is key to the success of your drug development programs, and is an integral part of our CRO services. Our project management team has extensive expertise in a wide range of study types and therapeutic areas in small and large molecules, and will oversee every aspect of your study.

We can help you navigate the program development landscape and prepare a study design that best accommodates your specifications and goals, while meeting the requirements of corresponding authorities. Our preclinical and clinical staff works in close collaboration to define your program needs, prepare investigational brochures, and ensure successful transitions between preclinical and clinical, for small and large molecules.

We are SEND compliant, and can prepare your SEND data package in as little as two weeks. Our specialists in SEND are active members of the CDISC SEND Consortium and PhUSE (Pharmaceutical User Software Exchange) nonclinical working groups.

Our scientists have extensive experience determining the relationship between the toxicological effects and the exposure of a new therapeutic entity in rodent and non-rodent species. Whether your test article needs to be detected by chromatography or ELISA, our broad range of GLP analytical services offered in our laboratories complements our in vivo capabilities to provide the exact data that you need.