Clinical Trial Solutions

Our Project Management Model ensures your needs are met by utilizing best-in-class project management solutions coupled with senior operational oversight and therapeutic leadership. This dual focus allows us to achieve a high quality of service and exceed your expectations.

We use a distinctive approach to project management which enhances our ongoing commitment to innovation and operational transparency. Our project management framework is focused on standardized quantitative and qualitative performance metrics for continuous process improvement. Importantly, our methodology allows for flexibility and customization while still maintaining the ability to efficiently produce reliable and high-quality results.

Our project managers are trained in our Foundations program where we emphasize and demonstrate excellence in ownership, accountability, and follow through. We dedicate highly trained Project Manager (PM) who functions as your primary source for information on your deliverable, simplifying the entire process as well as maximizing quality and efficiency. From study set-up, site-selection, database design and site communication, to monitoring visits, reporting and database lock, our PM proactively identifies and manages every risk to help ensure you receive consistent and meticulous results when you need them. Our PM creates a management framework to optimize the skills of team members and drives focus on the quality and efficiency of individual tasks.

Successful study start-up is an essential first step and relies on overcoming a range of factors. These include country and site selection, streamlining and proactive planning, and patient recruitment strategy — all of which can influence decisions and have a dramatic and positive impact on the conduct of the entire study

We provide customised solutions to meet the study start-up needs of our clients to deliver study start-up excellence with an experienced start-up team.

Our study start-up services include:

• Feasibility conduct
• Pre-study qualification/site selection visits
• Regulatory submissions/ IRB submissions/Research Ethics Submissions
• Investigator and other site staff training, Investigator meetings/Start-ups meetings

We offer targeted and risk based clinical site monitoring services to manage clinical studies on time and within budget. Our experienced monitors manage clinical trial by implementing technology-based solutions to provide efficient services and high-end results to the pharma, biotech, and medical device industries.

Our dedicated clinical monitoring team empowered with experienced CTLs /Sr CRAs / CRAs / CTAs ensure ICH GCP compliance and data integrity. Our monitors performs both on site and off-site monitoring visits. During each site visit our monitors identify and address issues in a timely fashion which ensures good quality and on-time data collection.

Our Monitoring services:

• Clinical Trial Site Management
• Clinical Trial Site Monitoring and Close out visits
• Quality Assessment Visits (co-monitoring visits)

Our Global Medical Services team comprise of experienced and trained physician who use industry and therapy area knowledge and expertise to develop and implement innovative, patient-centric solutions for drug development.

Our medical monitoring service covers all fronts including protocol development, ongoing trial management, investigators and site staff training as well as clinical study report writing.

While our medical team’s experiences and expertise vary, together they:

• Provide seasoned advice in most therapeutic areas or indications including clinical drug development strategy
• Share knowledge and experience in all phases of drug development
• Develop study concept design, protocol development, and study optimization tools along with biostatisticians, data managers and project managers
• Develop patient recruitment strategies in collaboration with investigators.
• Data Monitoring Committee and Data Safety Monitoring Boards
• Ensure the execution of the study in compliance with study protocol and GCP principles
• Provide clinical support to site staffs and site monitors during the conduct of the study
• Perform thorough data review to ensure data integrity
• Provide 24/7 medical cover for emergency unblinding and other study support

To help make use of most of the data you have worked hard to collect, our Clinical Data Management team is equipped with relevant expertise and experience to improve efficiency, reduce development costs and timelines, and anticipate risks.

Our data management team includes clinical data managers, database developers, programmers, medical coders, biostatisticians.

Our team develops data management and data quality plans during project start-up which is periodically reviewed and adapted throughout the conduct of study. These practices ensure accurate and consistent data collection, management, auditing, cleaning, and documentation. From periodic analysis and reporting, all the way through the regulatory process, we’re here to support you with fact-based guidance

Our clinical data management team is using the most advanced and comprehensive clinical data management software which meets the regulatory standards to ensure auditable GCP quality results to keep your drug development and medical device programs on track.

Our DM services includes:

• Case Report Form (CRF) and Database Design and development
• Clinical Data Management Plan and Validation Rules
• Data Cleaning and Query Management
• External Data Integration and Handling (Data Import/Export)
• Dictionary Services (MedDRA & WHODD)
• Reconciliation of clinical and safety databases

To ensure good sponsor oversight, you need to have a combination of tools, processes, and people. We have team with extensive Sponsor oversight knowledge and experience who have supported various industry clients in the past from initiation to close-out. We can integrate our team in a way that not only meet the needs of clients’ and regulators but also ensures the study compliance for delegated tasks and audit/inspection readiness in real time.

Our training program is a great place to start your career in clinical research. Our training curriculum has been specifically designed and developed in close collaboration with the experts from pharmaceutical industry and research professionals.

We have collaborated with Health Authorities and Medical Associations and are enhancing awareness of Good Clinical Practices to healthcare professionals and consulting with large hospitals to improve clinical research infrastructure.

We develop individualized training programs based on target audience. We have the knowledge and expertise to deliver efficient training programs covering all aspects of clinical trials with special focus on ICH GCP.

OrciTrials helps clients proactively meet regulatory requirements for drug safety throughout their product’s lifecycle. To meet increasingly complex and diverse global regulatory requirements, we have developed a comprehensive suite of services designed to ensure safety and expedite approvals. The entire process is monitored by licensed physicians who are trained to provide appropriate oversight and to analyse and evaluate the emerging safety profile of your compound.

Our experienced team members provide global safety processing and reporting services from database development to event reporting with complete documentation of the system validation and process implementation

Services

Our routine pharmacovigilance services include

• Set up and management of safety database
• Case processing including timely entry into and QC of the safety database
• Safety narrative writing
• Expedited safety reporting to regulatory authorities
• 24 hrs medical cover
• Signal Evaluation
• DSMB set up and support
• Scientific literature surveillance for signal detection as a part of routine PV activities
• SAE line listings
• Consistent and accurate coding of medical terms as per MedDRA and WHODD
• Development Safety Update Reports
• Periodic Safety Update Reports / PBRERs

Our experienced, trained, and certified auditors are based in all regions and ready to travel to the remotest sites to conduct audits to ensure quality and compliance of your studies and sites by conducting and supporting:

• Investigator Site Audits
• Vendor Qualification Audits
• Client/Sponsor Audits
• Regulatory Inspections

In case of Sponsor Audits and Regulatory Inspections we engage with your teams and site staff before audit/inspection dates to train and prepare them, while during the audit/inspection we provide on-site or remote support to manage and host interview and document review process. We also keep track of documents requested and issues identified. Post audit or inspection, we help develop and implement a robust CAPA until issue is resolved.

Our QA and Compliance Services:

• Developing audit plan
• Scheduling and coordination
• Identifying scope of the audit/inspection
• Audit conduct or Inspection hosting
• Report writing and distribution
• CAPA development and review
• CAPA implementation and issue resolution

APAN. Suppleness, experience of multidisciplinary projects and in-depth knowledge of regulatory environment are amongst the major strengths of OrciTrials.

Our regulatory affairs services:

• Consultancy services concerning the local regulatory provisions and requirements
• Liaison with local regulatory authorities and Ethics Committees
• Preparation/filing of CTA submissions and lifecycle maintenance of clinical trial authorizations in compliance with local regulatory requirements
• Compilation/review of Investigational Medicinal Product Dossiers (IMPD)
• Training in Regulatory Affairs

We provide end-to-end regulatory affairs services and expertise-driven product development advice from the early stages of development through to post-market support.

DEVELOPMENT STAGE REGULATORY AFFAIRS SUPPORT

Taking a product from the lab bench, towards clinical development and into patients takes years of expertise, effort, and expense. At OrciTrials we share our client’s passion to transition products towards the clinic and we excel in building regulatory considerations into product development programmes.

Our regulatory consultants do this by helping our clients with:

• Development plans and gap analysis
• IMPD / IND / Investigator’s Brochure writing
• Technical CMC regulatory expertise
• Orphan applications, PIPs, PRIME
• National and EMA scientific advice

CLINICAL TRIAL APPLICATIONS

As a boutique consultancy we have developed expertise in the strategy and submission of Clinical Trial Applications (CTA) for a broad range of product types. We also have current experience for the evolving national requirements in the field of cell and gene therapy. The services we offer include:

• Competent authority submissions
• Document authoring and coordination
• GMO applications
• CTA project management
• Ethics submissions

We manage the CTAs for a diverse range of clients, from biotech companies running a single trial, through to pharma companies with many new applications per year and a large volume of substantial amendments.

LICENSING AND PUBLISHING

At OrciTrials we provide a broad range of licensing, publishing, and allied services across all stages of development and in the post market setting. We provide support in the following areas:

• Assistance with all EU submission procedures
• Dossier reviews & gap analyses
• eCTD compilation: EU MAAs, US FDA INDs, NDAs & BLAs and post-approval submissions
• Preparation of non-clinical and clinical overviews and summaries
• Preparation of quality overall summaries
• PIL user testing
• E-liquids and TPD Notifications
• Conversion of NtA dossiers into CTD and preparation of eCTD baselines

POST MARKET REGULATORY AFFAIRS SUPPORT

Our regulatory consultants are experts in the life cycle regulatory affairs needs for all product types including solid oral dosage forms, sterile parenteral, locally-applied, locally-acting products (such as creams, ointments & eye drops) and hormonal products. We provide the following consulting services:

• Dossier preparation
• Life-cycle management of National, Mutual Recognition, Decentralised, and Centralised Procedures from preparation of initial MA applications through to full post-approval support and variations
• Outsourced Regulatory Affairs Department
• Regulatory Strategy
• Overflow Regulatory Affairs Department
• Training

Qualified study coordinators and site management associates are key to the successful management of a clinical trial. OrciTrials provides highly qualified and experienced Study Coordinators (SCs) and Site Management Associates (SMAs) to help support both principal investigators and sponsors. Through our SMO service, we provide principal investigators with trained SCs to assist with daily clinical trial activity and patient recruitment and sponsors with experienced SMAs to provide clinical trial site management and ethics committee support

Service details:

• Start-up activities and Study Management
• Ethics Committee communication and management
• Site contract, budget, expense management GCP documents/training review
• Subject recruitment and retention management
• Vendor Management
• Subject safety management
• Ensuring Study compliance
• Data entry and management
• Site team Training and Recruitment
• Source and TMF document generation and Maintenance
• Site Management and Operation
• Monitoring and auditing support.
• Recruitment of CRA, Study Nurse
• Electronic Data Capture (EDC) and Data Management
• Quality control
• Regulatory submission support