State of art facilities, partnership with leading organizations and large volunteer data base enable us to manage Phase I and BA/BE studies as per the ICH-GCP and regulatory standards. We ensure adherence to ethics, quality monitoring and integrity is never compromised.
Volunteer’s safety is our foremost priority and is managed by a highly specialized team of medical professionals whilst providing cost effective, speedy and high-quality solutions to biopharmaceutical/pharmaceutical clients.
As project manager plays a vital role in a study’s success, 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
OrciTrials’ medical writing team offers agile, expert support to help the client communicate clinical trial information to patients, sites, clinicians and regulatory authorities. We prepare quality medical writing deliverables for you with the right key messages for your required documents. Our medical writing team has expert medical writers who are supported by physicians
Our Medical Writing Services include (but not limited to):
- Study design concepts and study protocols
- Informed consent forms
- Investigational new drug (IND) applications
- Briefing documents and regulatory responses
- Clinical Study Reports (CSRs)
- Safety narratives for CSRs
- Aggregate safety reports (DSURs, PBRERs)
- Risk Management Plans including dRMPs
- Manuscripts, Abstracts and Posters
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
CH-GCP requires that sponsors must have a system to manage quality throughout the life cycle of the study. Even when activities are outsourced, including duties and functions sub-contracted to other parties by the CRO, the ultimate responsibility for quality and integrity of trial always reside with the sponsor who provides oversight.
A central lab for critical data (data that are critical to ensure human subject protection and/or reliability of trial results) is one example. Consider a misinterpretation of critical results and the harm that it may pose for a patient – how should that risk be controlled? Identifying risks to the quality of work performed by a CRO and other vendors allows the sponsor to actively manage those risks and reduce the likelihood of severe consequences.
Monitoring is one activity that’s generally outsourced. Risk-based monitoring is one method to control risk. ICH-GCP Guidelines provide flexibility in how you approach monitoring, but you need to justify the rationale for the strategy you have chosen.
FDA guidance on risk-based monitoring recommends periodic review of monitoring reports. Who is going to review those reports?
Do you have the required competency for continued Sponsor oversight? If you don’t, that is a serious risk to consider. You will be at higher risk of non-compliance, project delay or complete failure.
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
CASE STUDY
ATMP (Cell and Gene Therapy) Regulatory Support
The team at Orci-Trials has world class regulatory experience in assisting companies developing advanced therapy medicinal products (ATMPs). Support can be provided for both cell and gene therapy products for Europe and the US.
CASE STUDY
Development Support
The Regulatory Development Department has extensive experience in assisting companies to navigate through clinical development.
CASE STUDY
European regulation of ATMPs1
European regulations concerning the development of Advanced Therapeutic Medicinal Products (ATMPs) are complex and provide several additional challenges to sponsors developing gene therapies, somatic cell therapies and tissue engineered products.
CASE STUDY
Clinical Trial Application Service
The CTA team at OrciTrials is integrated into the Regulatory Development Department. The team has extensive experience in CTA activities for a wide range of product types.
CASE STUDY
Outsourced Regulatory Department
Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team.
CASE STUDY
Regulatory Department Overflow
Maintaining a headcount balance in regulatory affairs departments in the pharmaceutical industry is a perennial headache for any senior management team.
CASE STUDY
MAA SUPPORT AND LEADERSHIP: US TO EU
At OrciTrials, we have been successful in supporting US clients to transition their late-stage clinical development programmes through to Marketing Authorisation Application (MAA) in the European Union (EU).
CASE STUDY
ATMP (Cell and Gene Therapy) Regulatory Support
The team at OrciTrials has world class regulatory experience in assisting companies developing advanced therapy medicinal products (ATMPs). Support can be provided for both cell and gene therapy products for Europe and the US.
CASE STUDY
Development Support
The Regulatory Development Department at OrciTrials has extensive experience in assisting companies to navigate through clinical development.
CASE STUDY
European regulation of ATMPs1
European regulations concerning the development of Advanced Therapeutic Medicinal Products (ATMPs) are complex and provide a number of additional challenges to sponsors developing gene therapies, somatic cell therapies and tissue engineered products.
CASE STUDY
Clinical Trial Application Service
The CTA team at OrciTrials is integrated into the Regulatory Development Department. The team has extensive experience in CTA activities for a wide range of product types.
CASE STUDY
Outsourced Regulatory Department
Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team.
CASE STUDY
Regulatory Department Overflow
Maintaining a headcount balance in regulatory affairs departments in the pharmaceutical industry is a perennial headache for any senior management team.
CASE STUDY
MAA SUPPORT AND LEADERSHIP: US TO EU
At OrciTrials, we have been successful in supporting US clients to transition their late stage clinical development programmes through to Marketing Authorisation Application (MAA) in the European
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
