Service that inspires confidence

Providing clients with exceptional service since day one

Allphase Services

Allphase Clinical Research is known for to Exceeding Your Expectations® in the delivery of clinical research services. We provide:

  • Clinical Study Management
  • Clinical Study Monitoring
  • Data Management
  • Personnel Support
  • Post-Market Approval Programs
  • Quality Assurance
  • Clinical Supply Storage

Allphase also delivers:

  • Medical Writing
  • Biostatistics
  • Medical Monitoring
  • Regulatory Affairs
  • Product Development Planning

And through our sister organization Alio Health Inc.:
Home Health Care and Research Support

Affiliate Services:

Allphase Clinical Research offers clients additional capabilities by augmenting in-house services with those of affiliated partners to provide:

  • Central Laboratory Services
  • Ethics Review Board Services
  • Investigational Product Distribution
  • Translation Services
  • Access to a Global CRO Network

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Clinical Study Management

The role of the Clinical Study Manager is critical to the success of every project. At Allphase Clinical Research, our #bold#Clinical Study Managers#endbold# supported by our #bold#Clinical Study Associates#endbold# are experienced professionals trained to deliver superior service to our clients. Their collaborative approach combined with exceptional organizational and interpersonal skills creates a responsive client-driven environment.

Our services include:

  • Study start-up
  • IND/CTA maintenance
  • Collaborative interaction with regulatory authorities and IRB/ERBs, both local or central
  • Investigator site selection and feasibility assessments
  • Site contract and budget preparation, negotiation, and administration
  • Investigator meeting organization and site training
  • Investigational Product storage and distribution
  • CRA resourcing and mentoring
  • Monitoring report review and QA
  • SAE reporting coordination
  • Coordination of site/vendor/client communications and
  • On-time and on-budget performance

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Clinical Monitoring

Our #bold#Clinical Research Associates (CRAs)#endbold# are qualified and industry recognized for their outstanding reputation in client service, in-depth knowledge of industry regulations and guidelines, and therapeutic knowledge. They ensure compliance with protocols, quality standards, data collection, and regulatory guidelines. Our CRAs are regionally located across North America, reducing travel time and expenses. Our CRAs enjoy their profession as reflected in their interactions with clients, colleagues, and site staff as they perform their duties.

Our services include:

  • Site selection, initiation, interim monitoring, and close-out
  • Site personnel training, mentoring, and guidance
  • Assessing protocol compliance and data integrity
  • Regulatory document review
  • Pharmacy training and drug accountability
  • Ensuring adherence to GCP, consenting, confidentiality, and safety requirements

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Data Management

Allphase Clinical Research offers a full spectrum of data management services and expertise to optimize your data. Allphase staff are well trained and rigorously follow ISO 9001:2015 certified Standard Operating Procedures (SOPs) that encompass security, industry regulations, and GCP. Using state-of-the-art data management system technology, we always deliver a high-quality, unified database on-time.

Our services include:

  • CRF and database design
  • AE and medical coding and reporting
  • Internet-based randomization (IWRS)
  • Clinical trial safety database/ reconciliation
  • Lab data import
  • Single and double data entry
  • Electronic Data Capture
  • Query generation
  • Data validation, storage and archiving

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Post-Market Approval Programs

Our client’s needs rarely end at product launch. Phase IV studies and observational studies provide much needed #bold#real-world evidence#endbold# (RWE) of efficacy, safety, and health resource utilization. These studies constitute a rapidly growing segment of the industry, driven by regulatory requirements as well as healthcare provider and payer requirements.

Allphase aids its clients in developing post-market programs that are scientifically valid, focus on clinically relevant outcome measures, and accurately position your product within the market with respect to clinical outcomes and value.

Our post-market experience covers numerous forms of programs and includes:

  • Pharmacovigilance studies
  • Retrospective and prospective chart reviews
  • Observational (non-interventional) studies
  • Health economics studies
  • Quality of life studies
  • Randomized trials

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Medical Writing

Our experienced medical writers have advanced graduate degrees in biomedical sciences allowing them to deliver exceptional quality across a wide range of subject matter. We provide our clients with the highest scientific standards that meet all international guidelines and regulations.

Services include the development of:

  • Comprehensive literature reviews and competitive landscape due diligence
  • Clinical regulatory module preparation
  • Phase I-IV study protocols
  • Investigational drug brochures
  • Clinical study reports and safety narratives
  • Peer-reviewed original manuscripts and review papers
  • Presentation posters and abstracts
  • Technical briefs
  • Training manuals

Clinical Evaluation Report and Systematic Reviews

To ensure timely delivery of audit-ready results and complete process transparency, Allphase uses the DistillerSR and DistillerCER software platforms from Evidence Partners on all our CER and systematic review projects. This market-leading review software allows to seamlessly leverage client and external subject-matter experts, manage the complete review process and generate MedDev compliant reports through a prescriptive, standardized and easy-to-use interface.

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Biostatistics

Biostatistical design and analysis are central elements of any clinical trial. Establishing a sound biostatistical plan results in optimal study design and high-quality data output. Comprehensive statistical input during the early stages of a clinical development program decreases overall costs by accelerates timelines to regulatory approval. In addition, well formulated statistical plans improve the quality of regulatory submissions and increases the likelihood of approval.

Allphase biostatistical personnel keep current in all statistical analysis methodologies and have in-depth understanding of the practices deemed acceptable by regulatory agencies. Our Biostatisticians bring expertise and insight into the development of comprehensive statistical analysis plans (SAPs).

Our team assist our clients in navigating the complex areas of study design, including adaptive trial designs, sample size determinations, stratification methods, interim analysis options, final analysis methods, as well as data presentation, simulation, and interpretations. Our biostatisticians, programmers, and consultants make significant contributions to your drug validation.

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Medical Monitoring

Allphase works with experienced Medical Monitors to ensure that trial participants developing early signs of injury or disease as quickly as possible. Medical Monitors support our study teams with project specific training, review and provide input on protocols, investigator brochures, informed consent forms, case report forms, data management and validation plans. Allphase Medical Monitors support site staff, help develop the Safety Management Plan, support Serious Adverse Event (SAE) Management, coding, and of course, conduct safety reviews.

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Regulatory Affairs

Allphase offers regulatory support for a wide range of therapeutic products and indications on both national and international areas. Allphase Regulatory Affairs consultants provide regulatory and product feasibility advice on the development and commercial production of therapeutic, biologic, and device products.

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Product Development Planning

Bringing products to market costs time and money. Any mistake made along the way is expensive. As a result, product planning is critical. A well-conceived and comprehensive Product Development Plan provides a detailed assessment of your product and the most effective pathway to market, licensure, or clinical uptake. Allphase has expertise in providing qualified input for the planning and execution of successful strategies, allowing its clients to experience the benefits with significant value added to the project.

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Clinical Supply Storage

Managing clinical and medical supplies is critical in ensuring the successful completion of your trial. Allphase works with you and its partners to develop effective processes to facilitate timely and appropriate distribution of supplies making sure that everything is available when a participant requires it.

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