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Ora, Inc.

Andover, Massachusetts, US

Ora is the world’s leading full-service ophthalmic CRO and product development firm with offices in the United States, the United Kingdom and Japan. Over the past 40 years, we helped our clients earn 45 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects. We bring together the world’s most extensive and experienced team of ophthalmic experts and R&D professionals to maximize the value of new product initiatives.

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Medical Device Clinical Trials
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Preclinical Efficacy Studies
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As the largest ophthalmic-specific CRO, Ora has extensive experience across all facets of preclinical research, from identification and procurement of compounds to conduct of animal models, and management of GLP animal toxicology studies. Our Preclinical Experts focus on delivering clinically relevant endpoints and data, selecting... Show more »

As the largest ophthalmic-specific CRO, Ora has extensive experience across all facets of preclinical research, from identification and procurement of compounds to conduct of animal models, and management of GLP animal toxicology studies. Our Preclinical Experts focus on delivering clinically relevant endpoints and data, selecting the indication/s that correctly match your mechanism of action (MOA). We use refined endpoints in our ocular models, such as corneal staining in our Controlled Adverse Environment (CAE) for dry eye and redness or hyperemia in our Conjuctival Allergen Challenge (CAC) for allergy, to efficiently screen compounds. We also run retinal disease efficacy studies including the Laser-induced Rat Choroidal Neovascularization (CNV) studies and Experimental Autoimmune Uveitis (EAU).
http://oraclinical.com/ora/doc/Ora_Preclinical.pdf

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Preclinical Study Design
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Ora has an extensive R&D department and does custom model development based on clients' needs.

Ora has an extensive R&D department and does custom model development based on clients' needs.

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Regulatory Affairs Consulting
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Our regular interfaces with the FDA enable us to prepare informed clinical-regulatory strategies for our clients.
For over 30 years, Ora has scheduled regular interfaces with the FDA, enabling us to prepare informed clinical-regulatory strategies for our clients. We provide our clients with:

Our regular interfaces with the FDA enable us to prepare informed clinical-regulatory strategies for our clients.
For over 30 years, Ora has scheduled regular interfaces with the FDA, enabling us to prepare informed clinical-regulatory strategies for our clients. We provide our clients with:

  • Innovative and efficient methods for looking at therapeutics, while maintaining focus on the ultimate objective of timely marketing approval
  • Close interaction with divisions at the FDA for drugs, biologics, and devices
  • Deep international regulatory agency experience, including PMDA, EMA, B-Pharm, and DCGI

The Ora team frequently accompanies clients to the FDA to present plans and data. We also work with our clients in the development of:

  • Pre-IND strategies
  • Preparation and submission of pre-IND packages
  • Investigational New Drug Applications (INDs)
  • New Drug Applications (NDAs)
    • We can prepare the entire document, or prepare specific sections as requested by our clients
  • 510(k) Applications
  • Investigational Device Exemption (IDE) applications.
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Biostatistics
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For biostatistics services, Ora partners with our sister company, Statistics & Data Corporation (SDC). Since 2005, Ora and SDC have worked together on more than 100 phase I-IV studies, giving SDC unparalleled experience in designing, building, analyzing, and defending ophthalmic trials.

The biostatistician plays a key role... Show more »

For biostatistics services, Ora partners with our sister company, Statistics & Data Corporation (SDC). Since 2005, Ora and SDC have worked together on more than 100 phase I-IV studies, giving SDC unparalleled experience in designing, building, analyzing, and defending ophthalmic trials.

The biostatistician plays a key role in the planning and preparation of any study. From helping to design a cost-effective, optimal study, and providing the relevant statistical input on the study protocol to representation at regulatory meetings, our team is here to support you every step of the way. Key advantages to partnering with Ora/SDC for biostatistics services include the following:

  • Extensive libraries of standard ophthalmic Table, Listing, & Figure (TLF) summaries
  • Proficiency in converting ophthalmic data into SDTM standards
  • Experienced, driven project teams require minimal oversight from Sponsors
  • Seamless interaction between SDC and Clinical Operations teams at Ora
  • Dedication to timelines - over 98% on-time delivery of key milestones since 2011.
  • Rapid turnaround of top-line results consistently delivered within 3 days of database lock and full results delivered within 2 weeks of database lock
  • Comprehensive experience in communicating with the FDA ophthalmic division, via face-to-face meetings and teleconferencing as well as collaborating on the preparation of briefing packages and responses
  • SDC’s biostatistics leadership team brings extensive ophthalmic experience
    • Dale W. Usner, PhD, President - approximately 20 years leading and executing clinical trial research, including 10+ years in ophthalmic pharmaceuticals and devices
    • Kirk Bateman, MS, Director of Biostatistics – 12+ years leading and executing clinical trial research, including approximately 10 years in ophthalmic pharmaceuticals and devices

SDC’s Biostatistics Services Include:

  • Power and Sample Size Calculations
  • Study Design & Endpoint Development
  • Client Representation at Regulatory Agency Meetings
  • Randomization Schedule Preparation
  • Statistical Analysis Plan Development
  • Interim Analysis Planning
  • Data Monitoring Committee Planning and Reporting
  • SAS Programming and Independent Validation of TLFs
  • Meta Analysis/Post Hoc Analysis
  • Pharmacokinetic (PK) Analysis
  • Review and Support for Publications
  • Integrated Summaries of Safety & Efficacy (ISS/ISE)
  • CDISC SDTM and ADaM Standards
  • SAS-Derived Data Review and Interpretation Tools (i.e. Patient Profiles & P-Value Summaries)
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Regulatory Writing
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At Ora, the Regulatory Writing group is involved in all phases of our client’s drug development process.

Ora provides clients with a comprehensive ophthalmic drug development program. Regulatory writers routinely participate, along with Ora management and Ora’s clinical groups, in early discussions with potential clients. ... Show more »

At Ora, the Regulatory Writing group is involved in all phases of our client’s drug development process.

Ora provides clients with a comprehensive ophthalmic drug development program. Regulatory writers routinely participate, along with Ora management and Ora’s clinical groups, in early discussions with potential clients. The Regulatory Writing group then works with the Ora clinical group and the Sponsor throughout the course of the drug development project, preparing all necessary documents for submission to the U.S. Food & Drug Administration (FDA) and to the client. Regulatory writers support Ora’s clinical groups with literature searches on specific compounds, potential new drug targets or drug mechanisms of action so that they are well informed regarding development decisions. Often this material is used for trade journal or peer-review journal publications in an effort to heighten industry awareness of key issues and growing trends.

Comprehensive Regulatory Writing Services

The Regulatory Writing group provides a full range of writing services, either in support of a client’s drug development program, or as a stand-alone service. Ora’s Regulatory Writing group routinely prepares the following documents:

  • Briefing documents for FDA meetings
  • Investigational New Drug (IND) applications
  • Clinical protocols
  • Investigator’s Brochures
  • Clinical study reports
  • Patient safety narratives
  • Drug, device and biologic marketing application components
  • IND annual reports
  • Pre-clinical and scientific reports
  • Manuscripts for journal submission
  • Focused literature reviews and reports

Ora’s Regulatory Writing group maintains high standards for document clarity and quality. Document preparation proceeds with regular consultation to ensure that project needs are incorporated and that client preferences for presentation are followed. All documents are reviewed internally before being released to the client or to the FDA. All documents are prepared on time and are scientifically sound and fully compliant with any applicable regulatory guidelines.

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Clinical Development Strategy
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As the only ophthalmic-specific CRO specializing in preclinical models to phase III trials, our preclinical experience spans across all facets of preclinical research from identification and procurement of compounds to conduct of animal models, and management of GLP animal toxicology studies. As a fully integrated CRO, Ora... Show more »

As the only ophthalmic-specific CRO specializing in preclinical models to phase III trials, our preclinical experience spans across all facets of preclinical research from identification and procurement of compounds to conduct of animal models, and management of GLP animal toxicology studies. As a fully integrated CRO, Ora involves the appropriate Ora experts at the early stage of the development process, providing expertise in clinical-regulatory and program strategy, monitoring, medical writing, formulation/CMC, drug delivery, strategic business planning, and tailored marketing/advertising/commercialization solutions. Our integrated approach provides a seamless transfer of knowledge among our in-house experts and a more efficient development program. Ora customizes preclinical activities around a drug’s indication as well as its clinical significance to properly define metrics for value inflection. We also manage the efficiencies of our partners’ toxicology programs in order to help them move into the clinic as quickly as possible.

Ora offers our clients these expert preclinical services:

Market analysis
Outline for clinical, regulatory and marketing plan
Consulting services
Clinical indication selection
Understanding mechanism of action
Provide various development plans for MOA

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Data Management
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For data management services, Ora partners with our sister company, Statistics & Data Corporation (SDC). Since 2005, Ora and SDC have worked together on more than 100 phase I-IV studies, giving SDC unparalleled experience in designing, building, and analyzing ophthalmic trials.

When it comes to clinical trial success, data... Show more »

For data management services, Ora partners with our sister company, Statistics & Data Corporation (SDC). Since 2005, Ora and SDC have worked together on more than 100 phase I-IV studies, giving SDC unparalleled experience in designing, building, and analyzing ophthalmic trials.

When it comes to clinical trial success, data integrity is key. With a world class technological infrastructure and a team of top managers and directors, SDC is committed to providing the highest data quality, integrity, and security.

Through frequent coordination with clinical operations, SDC provides a seamless flow of data and a constant level of communication to ensure that projects meet deadlines and milestones, and keep clinical trials on track for timely conclusion. Our data management experts also fully understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.

Whether the trial is a large international study or a single-center proof of concept trial, SDC understands how crucial it is to get the project running efficiently. Clinical data management plays a key role from study startup through closeout and our team works seamlessly with clinical operations to meet all of the critical milestones of a sponsor’s project. SDC consistently meets or exceeds sponsor expectations in regard to both timelines and quality. Key advantages to partnering with Ora/SDC for data management services include the following:

Extensive libraries of standard ophthalmic eCRFs & edit checks
Experienced, driven project teams require minimal oversight from Sponsors
Seamless interaction between SDC and Clinical Operations teams at Ora
SDC has provided clients with over 98% on time delivery of key milestones since 2011
Expedited study startup & closeout timelines
Since 2009, Ora Monitors, Investigators, and site staff have been trained and are very experienced utilizing SDC’s database systems, including Oracle RDC and iMedNet EDC
Discrepancy management tool developed by SDC/Ora
Discrepancy trend metrics are fed upstream to project management, monitors, and sites to improve data entry quality over the course of a study
This same tool led to SDC/Ora being selected as a finalist for the 2011 SCDM Data Driven Innovation Award
SDC’s data management leadership team brings extensive ophthalmic experience
Dale W. Usner, PhD, President - approximately 20 years leading and executing clinical trial research, including 10+ years in ophthalmic pharmaceuticals and devices
Teri Hicks, Director of Data Management - 20+ years of industry experience in clinical and health information with therapeutic expertise in ophthalmology, medical devices, cardiology, endocrinology, infectious disease, and nephrology
SDC’s Data Management Services Include:
Data Management Trial Master File Set-Up and Maintenance
eCRF/CRF Design and Development
CRF and Diary Completion Instructions
Subject Diary Design and Development
Data Management Plan Development
Data Validation Manual Development
Edit Check Programming, Validation and Testing
Clinical Database Creation, Validation and Testing
EDC System Training for Sites & Monitors
Adverse Event and Concomitant Medication, and Medical History Coding
Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
Continual Data Cleaning and Query Reconciliation throughout Study
Independent QC Review
Development of Custom Status Reports upon Request
SAE Reconciliation between Safety and Clinical Databases
24/7 EDC Helpdesk
Development of Custom Status Reports to Excel

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Chemistry, Manufacturing and Controls (CMC)
Price on request

Ora’s CMC professionals offer distinct advantages within the ophthalmic development process to help your company quickly and efficiently advance your drug candidates to the next stage.

We have managed the supplies for numerous clinical trials, and we can adeptly handle complex designs and international studies.

In order to... Show more »

Ora’s CMC professionals offer distinct advantages within the ophthalmic development process to help your company quickly and efficiently advance your drug candidates to the next stage.

We have managed the supplies for numerous clinical trials, and we can adeptly handle complex designs and international studies.

In order to provide a one-stop turnkey solution to clients, Ora has built long-standing relationships with a strategic network of contract manufacturing organizations, suppliers, and consultants. Projects are assessed and defined in detail and then proactively managed to completion using established processes and best-industry practices.

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Patient Recruitment
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Clients around the world turn to Ora for our systematic approach to ophthalmic subject recruitment, which identifies and schedules qualified subjects quickly.

One of the most challenging aspects of clinical trials is patient recruitment - finding the appropriate patient population as well as the desired number of subjects for a... Show more »

Clients around the world turn to Ora for our systematic approach to ophthalmic subject recruitment, which identifies and schedules qualified subjects quickly.

One of the most challenging aspects of clinical trials is patient recruitment - finding the appropriate patient population as well as the desired number of subjects for a clinical trial to be meaningful.

Ora’s dedicated team of recruitment specialists has spent years identifying thousands of qualified ophthalmic subjects across a full range of therapeutic areas. Our in-house database is organized by disease state, such as such as allergy, dry eye, glaucoma, cataracts, diabetic retinopathy, and wet and dry age-related macular degeneration (AMD), and severity so we can easily meet the recruitment needs of specific trials and study phases.

In addition to recruiting subjects from our in-house database, Ora recruitment specialists collaborate with our investigative sites to develop site-specific strategies for properly identifying the desired study population from their patient base. Using Ora’s process of block enrollment- scheduling all study subjects before the trial start date, and working with OraNet - our network of established investigator sites experienced in conducting clinical trials within their area of expertise, we are able to meet the most aggressive study timelines.

We are also able to leverage our patient registries to provide our clients with valuable consumer market research information on their existing products, as well as new product concepts.

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Project Management, Consulting, & Support Services
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Data Services
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Animal Models and Studies
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Clinical Research
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Computational Modeling
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Biostatistics & Bioinformatics
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Marketing, Communication & Graphic Design Services
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Editorial and Writing Services
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Clinical Trials, Consulting, and Management
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Regulatory Affairs Services
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Formulation Services
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