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Company Overview of INC Research, LLC
INC Research, LLC operates as a clinical research organization that provides clinical development services to pharmaceutical, biotechnological, and medical device industries worldwide. The company offers early phase studies in the areas of abuse potential and liability, alcohol interactions, first-in-human, bioequivalence and bioavailability, biologics and chemical entities, central nervous system disorders, controlled substances, dose proportionality, drug-drug interactions, food effects, methadone interactions, pharmacokinetics, proof-of-concepts, protocols, tampering, and transdermal systems; and Phase I to IV studies. It provides late phase studies, such as patient registries (diseases a...
3201 Beechleaf Court
Raleigh, NC 27604-1547
Founded in 1985
Key Executives for INC Research, LLC
Chief Executive Officer and Director
Head of Clinical Operations in Germany
Chief Financial Officer and Executive Vice President
Senior Director f Oncology
Compensation as of Fiscal Year 2014.
INC Research, LLC Key Developments
INC Research, LLC Enters into a Credit Agreement with Goldman Sachs Bank USA
Nov 14 14
INC Research Holdings Inc. and INC Research, LLC (Borrower) entered into a credit agreement and related security and other agreements for $525,000,000 of senior secured facilities consisting of a $425,000,000 term loan facility and a $100,000,000 revolving credit facility with certain lenders and Goldman Sachs Bank USA, as administrative agent and collateral agent. The credit agreement governing the Senior Credit Facilities also permits the Borrower to increase term loan or revolving commitments under the term loan facility and/or revolving credit facility and/or request the establishment of one or more new term loan facilities and/or revolving facilities in an aggregate amount not to exceed $150,000,000, plus (x) in the case of any incremental facilities that serve to effectively extend the maturity of the term facility and/or revolving facility then in effect, an amount equal to the reductions in such loans or commitments to be replaced thereby plus (y) the amount of any voluntary prepayment of term loans under the term loan facility and/or any permanent reduction of the commitments under the revolving facility then in existence plus (z) an unlimited amount subject to (1) if such indebtedness is secured on a pari passu basis with the Senior Credit Facilities, compliance on a pro forma basis with a secured net leverage ratio of no greater than 3.25 to 1.00, (2) if such indebtedness is secured by a lien that is junior to the lien securing the Senior Credit Facilities, compliance on a pro forma basis with a secured net leverage ratio of no greater than 3.50 to 1.00 and (3) if such indebtedness is unsecured, compliance on a pro forma basis with a total net leverage ratio of no greater than a ratio of 5.00 to 1.00. The availability of such additional capacity is subject to, among other things, receipt of commitments from existing lenders or other financial institutions.
INC Research Signs Agreement to Perform FDA Due Diligence Audit of Regulatory Documents for Provectus Biopharmaceuticals
Oct 14 14
Provectus Biopharmaceuticals Inc. announced that it has retained INC Research to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10. The audit will be conducted in two phases, both of which are expected to be completed by early November 2014. In the first phase, INC Research Quality and Compliance Consulting will undertake a regulatory document inventory and evaluation of the contents of Provectus' information management system (the Smart Room). The results of this phase will generate a document request list, and the second phase of the audit will involve further evaluation of the requested documents. This will entail onsite verification of the regulatory documents and a final analysis of diligence issues identified in the audit.
INC Research, LLC Appoints Clare Grace as New Vice President of Site and Patient Access
Oct 7 14
INC Research, LLC appointed Clare Grace as the new vice president of site and patient access. In this new global leadership role, Dr. Grace will further develop and enhance the execution of INC Research's vision to create stronger connections with high-performance clinical research sites and targeted patient populations. Dr. Grace brings nearly 20 years of strategic global clinical research leadership to the company, including senior positions within the academic, pharmaceutical, biotech and CRO industries.
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