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SII Biotech Services Team is part of SII Life Sciences Vertical focused on serving to Biotech Companies. SII Biotech is committed to providing comprehensive services, integrated clinical and commercial solutions designed to help biotech companies move forward in their effort to get treatments to your treatments to the patient for first in human through Phase IV and post-marketing follow-through, launch and commercialization. We combine the global power and capabilities of SII with the hands-on approach, dedication and innovative mindset that drive the success of biotech companies such as yours.


The clinical trial protocol describes the objective, rationale, design, methodology and organization of a clinical study. Careful planning and consideration of device clinical trial study design is an important step in achieving the desired primary and secondary endpoints you desire in the most cost-effective and timely manner possible.

Depending on your ultimate goal, our device clinical consulting team will work closely with you to ensure that the clinical investigation plan appropriately represents you to Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) and adheres to Good Clinical Practice (GCP) guidelines, as well as all federal and local regulations.

The SII consulting team will help develop a medical device clinical trial protocol which includes:


Introduction which includes general information on the sponsor and investigational device, as well as background information about why the trial is being conducted, a description of the trial purpose and objectives including a statement of primary and secondary endpoints

The Clinical Investigational Plan which includes the following information:

o    Study design, subject selection, inclusion, exclusion and withdrawal criteria

o    Efficacy and safety assessments and variables

o    Overview of trial procedures and methods of assessment

o    Treatment administration, packaging and labeling, storage, subject assignment, disposition and compliance requirements

o    Adverse Event (AE) reporting including definitions of adverse events, serious adverse events, device-related events, pregnancy, events of interest and collection and reporting requirements

o    Statistical methods to be used, sample size, analysis plan, termination criteria, randomization methods, etc.

o    Ethical considerations including a description of the role of the Independent Ethics Committee (IEC) or Institutional Review Board (IRB), ethical conduct of the study, subject information and consent

o    Data quality assurance, source documentation and case report form completion, monitoring expectations, data handling, record keeping investigator training, audit/inspection procedures and handling of Personal Health Information (PHI)

o    Investigator selection criteria, study completion procedures and reference list

o    If applicable, Healthcare Utilization Information (HUI) collection and analysis procedures, customized appendices such as the Investigator Agreement, List of Abbreviations and Definitions of Terms, Informed Consent Form (ICF) template, etc.


Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical studies carried out in human subjects. It also serves to protect the rights, integrity, and confidentiality of study subjects. Compliance with this standard and ISO 14155 provides public assurance that the rights, safety, and wellbeing of study subjects are protected and that clinical data are credible.

Failure to address GCP / ISO 14155 compliance concerns from the beginning often results in delays in approval due to improperly designed studies, omitted studies, missing oversights and other failures to meet key regulatory requirements.


At the Sponsor/CRO:

  • Standard Operating Procedures (SOPs)

  • study documents – e.g., review of the clinical investigational plan (CIP)

  • processes – e.g., review for adherence to SOPs and regulation

  • systems - oversight, quality assurance (e.g., CAPA system)

At the study site:

  • study documents – e.g., completeness check of investigator site file (ISF)

  • processes – e.g., the procedure for obtaining consent Form (ICF)

  • qualification and performance

SII’ team has expertise in GCP and ISO 14155 compliance. Our medical device clinical professionals can conduct a GCP compliance check as described above and provide corrective action recommendations for your clinical study. Here is how we can help:

  • Ethics Committee and Regulatory Authority submission documents review

  • Clinical Investigation Report review

  • Trial Master File review


Our biostatisticians can provide valuable input to the design of your clinical study. We will conduct a thorough assessment of the scientific requirements to ensure your clinical study is planned with the proper sample size (number of patients included in the study) and design as well as the evaluation methods.

Proper protocol design and analysis will improve the quality of the medical device clinical study submission for approval, contribute to cost-efficiency, and help accelerate the introduction of your product to market.


Here are some of the clinical study biostatistics services we offer:

  • Input to the protocol design

  • Sample size calculations and justification

  • Statistical analysis planning

  • Interim/final statistical analysis and reporting

  • Creation of statistical summary tables and reports needed for regulatory submissions

  • Statistical support for Notified Body and FDA discussions

  • Extraction of datasets for scientific papers

  • Provide input for regulatory documents, such as input for CER, IFU, Summary of Safety and Efficacy


The success of any clinical study highly depends on the accuracy of the data collected. The SII clinical team and data manager will work with you to ensure data is collected, entered, verified, and reported according to the protocol and other requirements. Our goal is to provide you with the highest quality reliable data for analysis, following ISO 14155, ICH-GCP (Good Clinical Practices)


Our data management services include, but are not limited to:

  • Development of the Case Report Forms (CRFs)

  • Generation of Data Management and Data Validation Plan

  • eCRF Training

  • Database Management

  • Data review

  • Data processing for reporting

  • Data exports / transfers / digest


Clinical investigations with medical devices require one or more reviews of documents, systems, and procedures. These are independent examinations of clinical trial data and activities (including the company’s own oversight of the clinical study activities, if applicable). The intent of these reviews is to ensure the capture, analysis, and reporting of data in accordance with the study protocol and other approved documents, and compliance with GCP, regulatory requirements and Standard Operating Procedures (SOPs).

SII can quality review to any of the following regulations or standards:

  • Medical Devices Directive (93/42/EEC and 2007/47/EC)

  • Active Implantable Medical Devices Directive (90/385/EEC)

  • Medical Devices Regulation (MDR) - (study documentation only)

  • Good Clinical Practices (GCP)

  • ISO 14155

Medical device clinical study quality control experts

Our qualified team of medical device clinical professionals in Europe can assess compliance with all requirements outlined in the clinical study protocol, and provide corrective action recommendations as needed:

  • SOPs system/ Management Reviews

  • Trial Master File review/ quality control check

  • Process reviews

  • Investigator site inspection readiness assessments

  • Assessment of protocol compliance

  • Review of the adverse event reporting process

  • Clinical study report reviews/ quality check

To optimize the efficacy of this process, a detailed preparation will take place including, but not limited to the scope of the review, the review methodology, and the frequency of the reviews. Support may be provided on how to address the outcome/ correct findings of these reviews to ensure quality requirements are met for your medical device study.

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