Study No Sample Clauses

Study No. 182252 Set-Up And Pre-Validation Of An HPLC Method For The Determination Of BA058 And PTH In Dose Formulations Price: Price: (with [*] % [*] discount) Estimated 7-10 days* US$[*]/day US$[*]/day
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Study No. 182253 Validation Of An HPLC Method For The Determination Of BA058 And PTH In Dose Formulations Price: Price: (with [*] % [*] discount) US$[*] US$21,850 * Please note that the above price is based on an estimated number of days of work to be performed. Should the estimate differ from the actual number of days needed, the Sponsor will be invoiced accordingly. Please also note that the Sponsor will be updated regularly on progress. Please sign and return this document via facsimile or email as soon as possible (contact information provided below). Should you have any questions or require any additional information, please do not hesitate to call me. We look forward to being of service. Best regards, /s/ Xxxxxx Xxxxxx Xxxxxx Xxxxxx, MBA /s/ X.X. Xxxxxx Global Key Account Manager, Sales & Marketing Authorized Sponsor Representative Xxxxxxx River Laboratories Preclinical Services Montreal, Inc. 22022 Transcanadienne B.N. Xxxxxx Xxxxxxxxxx, Xxxxxx, Xxxxxx, X0X 0X0 Print (Name and Title) Phone: (000) 000-0000 Fax: (000) 000-0000 E-Mail: xxxxxx.xxxxxx@xxx.xxx Feb 11, 2009 Website: xxx.xxxxxx.xxx Date Xxxxxxx River * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. [LETTERHEAD OF XXXXXXX RIVER] accelerating drug development. exactly. Letter of Payment Authorization — Revision 1 16 August 2010 Xxxx Xxxxxxxxxx, PhD VP, Biology RADIUS 000 Xxxxxxxxxx Xxxxxx, 0xx Xxxxx Xxxxxxxxx, XX 00000 Phone: 000.000.0000 Email: xxxxxxxxxxx@xxxxxxxxxxx.xxx Dear Xx. Xxxxxxxxxx, We thank you for your interest in Xxxxxxx River and hope the attached proposal meets with your approval. For your convenience, we have provided the following summary of the title and price of the studies and/or study components under discussion. If you would like us to proceed with animal orders resource allocation, sign and date the authorization line below. This price is valid for 60 days, but may be modified by mutual agreement if changes to the scope of work are made.
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Study No. The sponsor hereby transfers to Aclires the responsibilities as indicated below. Responsibility Date Tasks Sponsor ACLIRES (planned) (actual) Study Preparation · Study Synopsis or Outline · Preparation of Financial Agreement · Study Protocol · CRF Preparation · CRF Review · Audit of the Protocol and CRFs · Informed Consent Form · Submission to Ethics Committees · Subjects Insurance · Submission to MOH (ANMAT) · Import of study drug · Packaging and/or Labeling of Study Drug · Resourcing of registered Study Medication (if needed) · Resourcing of Lab. Material · Randomization Schedule Responsibility Date Tasks Sponsor ACLIRES (planned) (actual) Study Conduct · Safety Laboratory · Pharmacokinetic Assays · Pharmacodynamic Assays · Shipment for PK / PD Samples · Monitoring · Site Initiation · Site Close-out · Reporting of SAEs to Authorities · Preparation of Amendments · On Site Audit Data Management / Statistical Analysis · Statistical Analysis Plan · Coding of AEs, cone. Therapies etc. · Data Entry · Database Validation · Database review prior to lock · Database Log · Data Transfer · Statistical Analysis · PK-Analysis · Statistical Report · Bioanalytical Report Responsibility Date Tasks Sponsor ACLIRES (planned) (actual) Study Close Out · Safety Summary · Integrated Clinical Report · Audit of Integrated Clinical Report · Drug Accountability · Return of Study Drug · Archiving of Study Documents · Shipment Costs for CRFs Responsibility Date Tasks Sponsor ACLIRES (planned) (actual) Others Development of Emergency Envelopes (patient specific) and delivery to site. Certificate of Analysis and GMP certificate
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