Contact a Biologics CRO Expert

Biologics Experience

Our CRO enables biologics, combination and biologic related device companies of all sizes to successfully execute clinical studies by streamlining the clinical trial process through an integrated approach that guides clients through the medical device lifecycle. Key areas of experience include:

•    Allografts and demineralized bone matrix products

•    Autografts

•    Bone cement

•    Bone Morphogenic Proteins (BMP)

•    Bone substitutes

•    Cartilage repair systems

•    Growth Factors

•    Hyaluronic acid

•    Orthobiologics

•    Platelet concentration

•    Resorbable fixation devices

•    Scaffold devices

•    Soft tissue and tendon grafts

•    Stem cells

•    Surgical glues

•    Surgical sealants

•    Synthetic cartilage

•    Xenografts

CRO Services

MCRA’s CRO team has proven expertise, accessibility to first-class facilities/equipment and dedicated staff to support biologics, combination and biologic related devices’ expedited route to market.

Our comprehensive CRO services include: 

•    510(k) Clinical Studies

•    IDE Clinical Studies

•    IND Clinical Studies

•    PMA Clinical Studies

•    De Novo Clinical Studies

•    Retrospective Clinical Studies

•    Clinical Database Selection

•    Clinical Research Compliance

•    Clinical Study Closeout

•    Clinical Study Logistics

•    Clinical Study Planning and Clinical Protocol Development

•    Clinical Site Budget Development

•    Clinical Trial Agreement Template Development

•    Clinical Trial Agreement (CTA) Negotiation

•    Clinical Trial Reimbursement Services

•    Clinical Trial Vendor Management

•    Data Management (DM) and Biostatistics (BS)

•    Database Development and User Acceptance Testing (UAT)

•    Data Safety Monitoring Board (DSMB) 

•    Clinical Events Committee (CEC) Meeting Services

•    Electronic Case Report Forms (eCRF)

•    FDA Audit Preparation

•    Investigator Identification

•    Investigator’s Meetings (IM) and Study Kick-off Meetings

•    Investigator & Study Coordinator Training

•    IRB Oversight and Management

•    Local & Central IRB Informed Consent Form (ICF) Template Development

•    Medical and Scientific Writing

•    Remote Site Management

•    Remote Source Data Verification (SDV)

•    Safety Management

•    Site and Sponsor Audit Preparedness

•    Site Selection and Qualification

•    Site Administrative Payment Management

•    Statistical Analysis Plan (SAP) Development

•    Statistical Programming

•    Study Start-up

•    Trial Master File (TMF) Set up, Maintenance, and Archival 

Contact a Biologics CRO Expert