Clinical & Regulatory Services

>Clinical & Regulatory Services
Clinical & Regulatory Services 2017-01-27T17:58:16+00:00

ARIANNE offers expert professional advice and know-how for execution of special projects.

Our services include program planning, regulatory affairs management, clinical services together with site and project management, clinical monitoring, medical monitoring, data management, biometrics, medical writing, and various consulting offerings.

While working with ARIANNE, you will benefit from the unique, extensive experience and commitment of our staff, the integrity of our systems, and the ability to conduct multi-center, international successful clinical studies.

Each of our offices has its own local proficient regulatory specialist and country director acting as a liaison between ARIANNE and the local regulatory agencies.  Each study has a shadow project manager in the US office available to answer US-based Sponsor questions without time delays. Similar settings are available for our international clients via our other offices in Europe and Africa.

Each Country Director is highly involved in your study from the beginning until completion to ensure superior service.

Our local offices have extensive experience reviewing and preparing documents to the ethics/regulatory committees of their respective country leading to a faster regulatory approval for our sponsors.

Country directors, together with their Project Managers and staff, are responsible for thoroughly reviewing all study designs prior to their implementation and ensuring SOP compliance of clinical sites.

Each study has a shadow project manager in the US office available to answer US-based Sponsor questions without time delays. Similar settings are available for our international clients.

ARIANNE provides global clinical trial support using our qualified staff. Each of our regional office staff performs all regulatory work, study set-up, and monitoring for ongoing trials -helping sponsors start up faster and reducing pass-through costs throughout the duration of the study.

Clinical Services

ARIANNE offers a full range of clinical study development and management services for all Phases (I, II, III and IV) of clinical research. All procedures are controlled by ARIANNE Standard Operating Procedures (SOPs).

Site Selection and Management

ARIANNE offers a full range of clinical study development and management services for all phases of clinical trial research (I, II, III and IV), outlined below. All procedures are controlled by Standard Operating Procedures (SOPs).

Site Selection and Training

ARIANNE conducts Site Qualification Visit(s) at selected clinical site(s). The site Qualification Visits are performed according to ARIANNE SOPs and Sponsors are welcome to participate in these visits.

siteselection

We will perform:

  • Identification and evaluation of adequate sites
  • Identification and recruitment of experienced investigators
  • On-site training of clinical personnel (clinical research coordinators and/or investigators)
  • Financial negotiations with sites and investigators and additional third parties (laboratories, radiology centers, etc.)

We work with experienced Investigators who have extensive research experience and highly trained staff. Each Investigator has conducted clinical trials and has a history of meeting and/or exceeding enrollment goals while maintaining quality data. The average number of years of research experience for Investigators varies from one country to another. In addition, in the United States, some of these investigators may maintain a private practice in his/her therapeutic area of expertise.

Sites have research experience is in the following areas, but not limited to:

  • Internal Medicine
  • OB/GYN
  • Urology
  • Cardiology
  • Endocrinology / Metabolism
  • Rheumatology
  • Gastroenterology
  • Pain Management (In and Out-Patient)
  • Pulmonology
  • Wound Healing
  • Dermatology
  • Family Practice
  • Asthma/Allergy
  • ENT
  • Infectious Disease
  • Surgery (In and Out-Patient)
  • Vaccine
  • Psychiatry/Neurology
  • PK Collections
  • Sexual Dysfunction

Site Management

Site Management is performed according to ARIANNE SOPs. ARIANNE conducts monitoring visits at regular intervals per sponsor requirements. The first visit is often conducted when the first patient is dosed, then interim monitoring visits are conducted at agreed upon intervals for all site(s).

During on-site monitoring visits, ARIANNE executes the following tasks to monitor compliance with GCP:

  • Perform 100% review of all signed Informed Consent Documents
  • Perform 100% source document verification of all key safety data
  • Review all non-key clinical data at the site for legibility, completeness and consistency within the CRF set
  • Instruct clinical site staff to supply missing data, complete data corrections, and clarify CRF information
  • Check data clarifications against source documents to confirm that all clarifications have been made on the CRF and accurately reflect the source documents
  • Monitor drug accountability, including the reconciliation of inventory
  • Periodically review required clinical site regulatory documentation and provide updates to Sponsor
  • Document deficiencies and follow-up until they are corrected by the clinical site staff

The monitoring visits are documented in Monitoring Visit Reports and follow-up letters are sent to the site and provided to the sponsor.

Site Management Services:

ARIANNE acts as the link between the sponsor and the investigators/sites. Our responsibilities include, but are not limited to:

  • Regulatory document collection, clearance and update
  • Obtain local ECs/IRBs approvals
  • Regular and ongoing communication with the sites to follow study progress
  • Maintain study binder on site
  • Ensure site compliance to study and regulatory requirements
  • Oversee integrity and quality of data
  • Assure patients safety
  • Preparation and distribution of newsletters
  • Oversee laboratory sample processing and shipments to third parties when required
  • Oversee drug requests, shipments and receipts
  • Ensure adequate availability of study supplies at sites

For many clinical trials, local laboratories are used for the testing of routine laboratory samples. ARIANNE ensures that each local laboratory accepted for a clinical trial has the proper certifications and current reference ranges.

For more specialized testing, such as unusual tissue antigens testing, study specific biomarkers, we assure the proper collection and safe shipment of samples to the central laboratories of sponsor preference.

Team Communications

teamARIANNE manages all projects with a team-minded approach. For each study, ARIANNE designates a Project Manager. The Project Manager will have the primary responsibility of communicating with the Sponsor for overall project information for the duration of the project. The communications include daily, weekly and monthly updates to keep core team members current on all project activities. Authorized sponsors can view real time results through our web-based clinical trial management system (CTMS)—allowing them to see updates on patient enrollment, monitoring, and standardized reports. These reports are also provided to the sponsor electronically on a weekly basis. ARIANNE is committed to timely and efficient management and optimized communications for your clinical studies by combining the following information:

  • Project team communications – contact information and e-mail links for all ARIANNE and sponsor project team members; regular teleconferences for ongoing project team communication
  • Administrative information – contracts, meeting minutes, SOPs and other documents supporting our partnership
  • When requested, online centralized documents, read-only access to key project documents such as protocols, CRFs, review guidelines and key project milestones
  • Project status reports – customized reports developed by the project team to your specifications

Security Commitment

We host studies on servers dedicated to our sponsors and located securely behind multiple firewalls. Using server-based security, each site requires authentication and authorization of anyone trying to access a site, as well as encryption for all transactions and communication between user and site. As part of standard procedure, all files and programs are fully backed up by ARIANNE on a daily basis.

 

Patients Registries and Observational Studies

Observational studies are an important category of clinical study designs. Well-designed observational studies have been shown to provide results similar to randomized controlled trials, challenging the belief that observational studies are not beneficial and informative. Cohort studies and case-control studies are two primary types of observational studies that aid in evaluating associations between diseases and exposures.

There is recent interest in observational trials from regulators, companies, physicians and patients to better understand diseases and their impact on patients.

ARIANNE provides support for the development and execution of observational studies. We design and execute post-marketing studies in compliance with FDA-ICH and regional regulatory guidelines. We adhere to strong research principles and strive to provide quality data.

  • Observational studies
  • Registry studies
  • Health outcomes and economics
  • Patient reported outcomes/Quality of life
  • Risk-benefit and risk management evaluations
  • Retrospective and prospective post-approval pharmacoepidemiology and drug safety studies
  • Database “mining

Our teams throughout the regions we cover provide our clients with support and insights during the development cycle of your programs. Our teams’ tailor their activities based on the specificities of each study and will get involved based on your requirements in:

  • Study design
  • Regulatory
  • Project management
  • Protocol development
  • Site Management
  • Study Document Development
  • Recruitment
  • Data management and Analysis
  • Quality Assurance
  • Medical Writing

 

Data Management

Data Management is an integral component of ARIANNE’s global capabilities. We provide our clients with comprehensive data management plans prior to study initiation, along with on-going reporting.

We use validated data management softwares and can deliver database in any format.

We can deliver the database in a format that matches the sponsor’s requirements and systems. In order to achieve a worldwide consistency, we centralize design and control of each project-specific database under a lead data manager, supported by the company’s global standard operating procedures (SOPs). The data management planning process emphasizes close communication with the sponsor through all phases of development and review of database specifications. Quality Control mechanisms are in place to monitor every major element of the data management process.

Quality Control is built into every step of ARIANNE‘s data management process to guarantee quality.

Data Management services include:

  • CRF design
  • CRF tracking
  • Project timelines
  • Data entry guidelines including protocol-specific guidance
  • Database design
  • Programming
  • Data quality validation
  • Query management
  • Thesaurus coding/Lab data administration
  • Study close-out/database lock
  • Quality control and assurance (queries and data)
  • Status reports (any format, including web-enabled secure access, when requested)

Drug Safety

ARIANNE provides complete safety services. We have proven processes and systems for managing reports of Serious Adverse Events for all our clinical trials within the United States or globally. Our investigators have access to dedicated medical personnel 24-hours-a-day via safety telephone services. Our team consists of experienced physicians, nurses, and clinical data specialists with extensive years in drug safety management.

We provide:

  • Customized safety plans
  • Clinical and post-marketing adverse event (AE) and serious adverse event (SAE) management from initial data collection through regulatory reporting
  • Written medical evaluations including narrative preparations, causality assessments, follow-up information from the investigational sites and when requested, recommendations for reporting to the various international regulatory agencies
  • SAE reporting in an agreed format to your clients or to the regulatory agencies
  • Expedited US and International case reporting
  • Preparation and submission of periodic reports and periodic safety update reports to meet Regulatory obligations
  • Safety database management
  • Reconciliation with CRF pages

Biostatistics

The right data analysis is critical for study success. ARIANNE’s biostatisticians are committed to your success starting with a well-thought and carefully designed analysis plan all the way through to the analysis of study data.

Analysis Plans

Concise, accurate reporting of study results begins with development of clear protocols and accurate, user-friendly case report forms. Our statisticians interact with sponsor scientists to develop a comprehensive statistical analysis plan, including:

  • Overview of study objectives
  • Description of study population
  • Sample size rationale and statistical power
  • Methodology for summary and analysis of demographic, baseline, efficacy and safety data
  • Description of statistical methodology
  • Shells of all planned tables, listings and graphs

Statistical Analysis

Based on a well-developed analysis plan, statistical analysis implementation provides sponsors with timely, high-quality deliverables. We ensure complete, concise reporting through:

  • Production of tables, listings and graphs in compliance with FDA and ICH guidelines
  • Development of comprehensive methods reports that document planned and exploratory analyses
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results
  • Methodology for summary and analysis of demographic, baseline, efficacy and safety data

Statistical Consulting Services

In addition to providing expert statistical support for individual studies and programs, our statisticians provide consultative statistical support, including:

  • Program development advice
  • Statistical methodology review
  • Analysis interpretation
  • Report review
  • Presentation to regulatory authorities
  • Data Safety Monitoring Board (DSMB) participation

Medical Writing

ARIANNE provides a wide range of medical writing services for all phases of the clinical trial process. ARIANNE’s Medical writing team consists of highly knowledgeable individuals with various advanced degrees, a wide range of clinical research experience and extensive knowledge of the clinical, biostatistics, and regulatory processes.

ARIANNE provides the following services:

  • Protocol development, review and updatemedical-writing
  • Investigator’s Brochure (IB) and IB amendments
  • Development of Informed Consent
  • Medical and safety report writing
  • Development of operation manuals
  • Planning and writing of summary documents
  • Study summary reports (preparation, review and submissions)

Quality Assurance

ARIANNE is committed to quality. We have quality assurance review processes in place for all stages of your product development and we conduct audits early and at measured intervals to identify and proactively limit any impact on your program.

Site Management QA Services

Conducting audits early in the clinical stages of development identifies systematic problems with the conduct of your study, such as misinterpretation of protocols. These audits enable early intervention and corrective action to avoid preventable delays and expense in the conduct of your program.

  • Our auditors have expertise in individual country requirements as well as FDA/ICH clinical research requirements.
  • Our QA personnel are accustomed to working as a team with your organization. At no additional cost to clients, we share information on mutually agreed audit plans and discuss QA and compliance issues with you.

We offer:

  • Individual site audits
  • Document audits
  • Internal system audits — audits of SOPs, documents and staff training for improvement of efficiency and compliance
  • Investigator-directed audits — investigation of questionable data for clients
  • Team members have hands-on experience in FDA audits
  • Vendor audits of subcontractors, such as central lab investigational study materials
  • QA consulting
  • We can provide independent auditors when requested

Data Management QA

Additionally, though our partners, we can provide you centralized laboratory, analytical, IVRS, Specimen storage, and radiology services. Quality Assurance review processes are in place for every major element of the data management process and deliverables.

  • Database set up
  • Validation manual
  • Programmed edit checks
  • External transfers
  • Overall database quality
  • 100% of defined critical variables reviewed
  • 10% of randomly selected CRFs are 100% manually reviewed against the database at intervals throughout the study, as well as just prior to database lock

In addition, we track and review performance measures, such as query rates by type, numbers of queries and the ratio of errors to total units. We use this information to continuously improve the quality of the data management deliverables to our sponsors.

Statistical QA

Independent quality review assures statistical practices are consistent with the study’s scientific design. We plan quality into the preparation of biostatistics deliverables through our working practices.

  • Programming and quality review based on written specifications
  • Use of validated software and macros
  • Standardized programming processes and directory structures
  • Independent validation of all project-specific programming
  • Quality review of all outputs for accuracy and to document audit readiness
  • Senior review of all deliverables — from protocols through regulatory submission documents

Regulatory Affairs

US and International Regulatory Affairs Services

ARIANNE can provide regulatory assistance for all types of products (small and large molecules, biologics and devices). We provide support for all phases of product development for the FDA and international regulatory agencies.

  • Regulatory strategic planning
  • Liaise with regulatory agencies (e.g., FDA, Canadian, EU and Non EU, Asian agencies)
  • Global sponsor representation
  • Document preparation and submission for clinical studies (INDs, IND Amendments, CTAs)
  • Pre-market submissions, IDE/510(k)/PMA
  • Investigational medicinal products dossier (IMPDs), NDAs and BLAs preparation and submissions
  • Electronic submissions
  • Preparation and submission of orphan drug designation applications
  • Submission and review of IRB approvals for clinical studies
  • Preparation and review of investigator’s brochure and updates
  • Safety report writing, safety monitoring and SAE reports
  • Preparation of annual regulatory reports
  • Regulatory operations; procedural review and audits