Clinical Research Services
With the recent changes in rules and regulations, a well-planned clinical investigation complying these regulations is essential to achieve study objectives and goals set.
The Clinical Research Services (CRS) group at LandmarkCRO has a high level of expertise with plenty of experience in conducting clinical trials in different therapeutic areas.
We are committed to providing high standard, technology-driven clinical research services to pharmaceutical and medical device companies helping them in designing, development, and execution of clinical studies through all phases.
We also have the flexibility to choose from our full range of services as per your requirements.
Services Provided By Clinical Research
Protocol & Other Study Documents Preparations
The Clinical Study Protocol is considered as the most important document for the successful execution of clinical trials.
It allows the manufacturer to critically evaluate the safety and efficacy of a drug or device in the target patient population and provides the way for the drug or device to get through market approvals.
Thus, writing the clinical study protocol must involve a good focus on ethical, clinical, and regulatory requirements provided by different regulatory authorities of the respective country or region.
At LandmarkCRO, our medical writing experts are well-trained on GCP guidelines and are ready to assist you in drafting the clinical study documents including the protocol, informed consent form, investigator brochure and other relevant documents as per your requirements.
Clinical Operations
The endeavor of LandmarkCRO shall be to ensure sustained compliance on clinical trial quality as well as study deliverables with excellence and offer critical as well as practical solutions throughout all phases of a clinical trial namely – project planning, trial/site initiation, study conduction, and study closure.
We aim to contribute to managing site as well as clinical operations activities with precision and utmost quality standards.
The LandmarkCRO team have immense experience in the medical device and pharma sectors, and we assist our partners for:
- Project management including study planning, execution and closure ensuring compliance at all levels
- Monitoring of studies ranging from first-in-human to post-marketing clinical follow-ups and post-marketing surveillance (PMS) studies
- Regulatory consulting and coordination
- Institutional ethics committee coordination and support
- Vendor management
- Study document compilation and adaptation as per local regulatory requirement.
We also provide dedicated services to conduct Investigator-Initiated studies, and we have professional experience of conducting such studies with key opinion leaders (KOLs).
The Clinical Operations team at LandmarkCRO is full of driven and cross-functional people with assorted knowledge and expertise in accomplishing and managing clinical trials in all phases and covering diverse therapeutic areas including pharma and medical device arena.
At LandmarkCRO, we have a team of highly qualified professionals with extensive experience across multiple therapeutic areas and well versed with GCP guidelines and pertinent local country regulations. . Professionals at LandmarkCRO with significant associations in the Medical Device field with a client-oriented and can-do approach, proactively find innovative solutions.
Data & Safety Monitoring Board (DSMB)
The Data and Safety Monitoring Board (DSMB) is a group of independent experts that reviews the study data periodically to monitor and evaluate safety, overall study conduct and when appropriate, efficacy during the conduct of the study.
The DSMB also makes recommendations on continuation, modification, or termination of the study.
DSMB services offered by us include:-
- DSMB Charter/Manual preparation
- Recruitment of DSMB members & contract negotiation
- Prepare reports/slides for the meeting
- Statistical analysis of study data
- Conduct of the meeting minutes
- Accumulation & review of study data from different sources (Sponsor, sites, central lab)
- Blinded & un-blinded analysis & reports.
Event Adjudication (Clinical Event Committee - CEC)
The Clinical Event Committee performs an independent adjudication of clinical events reported by the investigational sites or core labs or central labs and classifies these events as per the study endpoints.
The CEC also performs a causality assessment of these events with respect to study product/device/procedure.
CEC services offered by us:–
- CEC Charter/Manual preparation
- Adjudication form preparation
- Recruitment of CEC members & contract negotiation
- Event triggering, document collection & event dossier preparation
- Conduct of the meeting & minutes
- Report preparation